Material Risks CSL operates in a fast paced and constantly evolving environment of science, technology and healthcare. Although there are many risks inherent in operating in these environments and industries, for example research and development, intellectual property and clinical trial risks, CSL regularly reviews its group risk profile to identify and assess material business risks. This includes external and emerging risks that could affect CSL’s global operations. CSL is also exposed more broadly to external risks such as the escalating trend of cyber threats and data privacy breaches. Managing risks includes both the mitigation of disruptive risks and the preparation for seizing opportunities. CSL’s Global Enterprise Risk Management Framework is designed to provide robust risk oversight that is fit-for-purpose for both the operation of CSL’s business and to support CSL’s strategy and deliver on CSL’s commitments to patients and public health. As part of CSL’s enterprise risk management process, the Board and management team have identified the key risks that are material to CSL. These material group risks are described below along with an explanation of CSL’s approach to managing them in the context of delivering on CSL’s 2030 Strategy. Key financial risks are set out in Note 10 (Financial Risk Management) to the Financial Statements. There are other risks that are inherent in the vaccine, plasma and recombinant proteins therapies and pharmaceutical industries, including iron deficiency, besides those detailed below or in the Financial Statements, that could also adversely affect CSL’s business and operations. These risks are not covered in this report as they are not considered material to CSL’s overall operations and financial position. Patient safety and product quality Patient safety is paramount for CSL’s ongoing sustainability as a global biotechnology leader and CSL’s long‑term strategy of efficiency and reliable supply. 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. Occasionally, patients and trial participants may sometimes experience adverse reactions to therapies, CSL’s manufacturing, product quality assurance and pharmacovigilance practices serve to provide high standards of safety and preserve CSL’s reputational integrity. CSL’s processes and procedures adhere to global good pharmacovigilance practice (GPV) and good clinical practice (GCP) standards to ensure that product information is up-to-date and contains all relevant information to assist healthcare practitioners to appropriately prescribe CSL products. For clinical trials, CSL prioritises informing participants about their disease (if applicable) and the investigational therapy involved in the trial before obtaining consent. Participants 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. Comprehensive qualitative and quantitative safety signal detection activities are performed throughout the development programs and the lifecycles of CSL’s marketed products. In terms of meeting product quality requirements through CSL’s manufacturing and supply, CSL adopts and complies with a broad suite of internationally recognised standards through the CSL Quality Management System, including good manufacturing practice, and good distribution practice (GDP) that includes audits of third-party vendors and suppliers. CSL is frequently inspected by independent regulatory authorities auditing compliance with these standards. Product innovation and competition CSL recognises that an impediment to delivering on CSL’s innovation and sustainable growth strategies is the changing competitive landscape for new technologies and disruptive therapies, such as gene and cell therapies. This material risk may alter the economics and characteristics of, and the demand for, CSL’s plasma and adjacent therapies, and may also affect the platforms and capabilities in plasma protein technology, recombinant protein technology, cell and gene therapy and vaccines technology. CSL continues to seek out new and unexplored avenues to tackle the most pressing medical challenges and remains committed to investing in targeted and disruptive R&D innovation to better meet the needs of patients and public health. CSL strategically reviews its existing and future product pipeline against unmet need and market demand and continually evaluates the competitive landscape. A key part of CSL’s strategy includes thoughtful diversity through multiple therapeutic areas and scientific platforms. CSL incorporates product lifecycle development and management, as well as development of new therapies, in strategies for each therapeutic area. In addition to proprietary research, CSL’s competitive approach includes licensing, acquiring or partnering with third parties to remain competitive and advance growth within CSL’s chosen therapeutic areas. In addition, clinical studies in new therapeutic and disease areas carry an inherent higher initial risk of failure as well as operational and technical challenges, due to the potential for knowledge gaps in the relevant medical, scientific and regulatory environment and the uncertainty of therapeutic outcomes. With respect to continued growth and innovation in the competitive global influenza vaccine market, CSL recognises the need to continue leading in the development and manufacture of influenza vaccines including cellculture technology and investigating the use of sa-mRNA technology for the development of both influenza and COVID-19 vaccines. Embracing innovative technology is important in this product sector, unlocking competitive advantages for success. 14 Limited Annual Report 2023/24
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