CSL Ltd Annual Report 2021

We respect the trust that is placed in us by our stakeholders globally. To continue to earn that trust is a driving force throughout our business and is critical to our ongoing success. Trust drives value. We earn stakeholders’ trust by demonstrating responsible behaviour in our activities and decisions. Responsible conduct in the marketplace protects our reputation and sustains organisational growth. Around the world, patients and healthcare professionals know that they can rely on the quality, safety and efficacy of our therapies. International organisations such as the World Health Organization rely on us to help prevent and prepare for influenza pandemics. Governments and regulators understand the ethical approach we bring to development and registration of our products and our commitment to fair pricing. Investors see that this trust and positive reputation is reflected in our strong financial performance. US$9.9 billion distributed in supplier payments, employee wages and benefits, shareholder returns, government taxes and community contributions* Product quality and safety The development, manufacture and supply of high-quality and safe products is critical to our 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. These are reflected in global policies and local procedures, as well as global electronic systems to support management of the quality processes. In 2020/21, despite the COVID-19 pandemic, CSL’s quality systems, plasma collection and manufacturing operations were subject to 365 good manufacturing practice (GMP) regulatory agency inspections around the world. These independent inspections resulted in no suspensions or terminations of a licence to market a product in any market in which CSL is active and confirm that the quality systems established globally by CSL are effective and in line with regulatory agency expectations. In addition, as a new process resulting from the COVID-19 pandemic, CSL responded to 65 requests from regulators for electronic documents (record review requests) over the reporting period. 365 regulatory inspections of our manufacturing facilities with no impact to licenses* 481 quality audits of our suppliers † During the reporting period, CSL Behring initiated three voluntary safety-related product recalls.* There were no recalls initiated by regulators. • In January 2021, CSL Behring, Kankakee, US, initiated a recall across 20 markets for 147 batches of ZEMAIRA ® / RESPREEZA ® and MONONINE ® due to HEPA filter integrity test failures in the filling suites. • In March 2021, CSL Behring, Marburg, Germany initiated a recall of RESPREEZA ® in Germany, Austria and France for 10 batches. CSL Behring was notified by a third-party supplier that the sterility assurance of manufactured infusion sets used in packaging with RESPREEZA ® could not be guaranteed. • In April 2021, CSL Behring, Bern, Switzerland initiated a recall of one batch of HIZENTRA ® due to an increase of injection site adverse events reported for the recalled batch. To assure continued consistent high-quality materials from our partners, CSL Behring and Seqirus conducted a combined 481 quality (GMP) audits † of suppliers worldwide, comprised of on-site, virtual and paper-based audits. Over the reporting period, there were 17 reported cases of counterfeit product; 10 of these were confirmed as counterfeit, five were CSL products, and two cases had limited data available or remain under investigation. Oversight and management of pharmacovigilance and clinical safety affords our patients the opportunity to fully realise the benefits of our products. CSL’s Global Clinical Safety and Pharmacovigilance function continues to assure the safety of patients and clinical study participants while further deepening its capabilities and improved quality outputs. Compliance metrics have remained at high levels. 64 pharmacovigilance audits of CSL and third-party operations with no outcomes diminishing reliable supply of quality product Over the reporting period, CSL Behring and Seqirus pharmacovigilance quality assurance (PVQA) performed a total of 64 pharmacovigilance (PV) audits: – 22 on internal systems and processes across our sites, including affiliates; and – 42 on third parties that undertake PV responsibilities on CSL’s behalf in various countries all over the world. Seqirus also underwent one successful regulatory pharmacovigilance inspection by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). None of these audits resulted in an outcome which affected our ability to supply product. * Limited assurance by Ernst & Young. † Does not include CSL’s operations in Wuhan, China. Limited assurance by Ernst & Young. CSL Limited Annual Report 2020/21 43 9 A TrustedHealth Partner