In December 2023, one CSL Behring lot of PRIVIGEN® was recalled* from the Canadian market due to a higher rate of allergic/hypersensitivity type reactions. Hypersensitivity and anaphylactic reactions are a known risk with immunoglobulin products. In June 2024, CSL Vifor recalled* 30 mL Maltofer® drops as precautionary measure due to the presence of plastic particles from the dropper in some units attributed to the packaging process performed at the contract manufacturer. This year, there were eight counterfeit products reported to and confirmed by CSL Behring. CSL Behring is evaluating packaging security solutions that will make it more difficult for counterfeiters to replicate CSL’s products and will make identification of counterfeit products easier. In addition, CSL Behring is working with health authorities to raise awareness and educate customers on how to identify, handle and report suspected counterfeit products. Over the financial year, CSL underwent several good manufacturing practice inspections that involved patient safety and pharmacovigilance (PV), one combined European Medicines Agency (EMA)/US Food and Drug Agency (FDA) pre-approval inspection and one local PV inspection by the Health Authority of the Netherlands. None of these inspections identified any significant failing of the pharmacovigilance system and for the findings identified, CSL’s proposed actions were considered appropriate. In addition, CSL pharmacovigilance and regulatory quality assurance (PVRQA) performed a total of 82 PV audits for CSL Behring, CSL Seqirus and CSL Vifor to support a robust pharmacovigilance system. None of these audits resulted in an outcome that affected CSL’s ability to supply product. Product quality and safety The development, manufacture and supply of high-quality and safe products is critical to CSL’s ability to continue to protect public health, save lives and improve the health and wellbeing of patients with rare and serious diseases. CSL employs an independent quality function that strives to maintain the highest standards through the use of global quality standards and systems. These are reflected in global policies and global and local procedures, as well as global electronic systems to support management of the quality processes. In the reporting period, CSL’s quality systems, plasma collection and manufacturing operations were subject to a total of 479 regulatory agency inspections* around the world. Of these, 31 good manufacturing practice (GMP) regulatory agency inspections* took place at our manufacturing facilities and distribution centers, and 448 regulatory inspections* at our plasma collection centres. These independent inspections resulted in no critical findings that prevented release of commercial product and no suspensions or terminations of licenses to market any products in markets in which CSL is active. These results confirm that the quality systems established globally by CSL are effective and in line with regulatory agency expectations. Guided by CSL’s Community Contributions Policy and investment focus areas of support, in 2023/24, CSL contributed US$45.3 million to support global community efforts where we operate. * Limited assurance by Deloitte. 479 regulatory inspections resulted in no critical findings that prevented release of commercial product, no suspensions or terminations of licenses to market any products in markets in which CSL is active* US$13.5b Economic value distributed over the reporting period in supplier payments, employee wages and benefits, shareholder returns, government taxes and community contributions* 57% to patient communities 41% to innovation and science 2% to local communities • Enhancing quality of life for patients with the conditions our therapies treat • Improving access to our biological medicines • Advancing knowledge in medical and scientific communities • Fostering the next generation of medical researchers • Supporting community efforts where we live and work • Supporting communities in times of emergency FOCUS AREA^ SUB FOCUS AREAS 43
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