CSL Ltd Annual Report 2020

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$8.8 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 2019/20, CSL’s quality systems, plasma collection and manufacturing operations were subject to 401 good manufacturing practice (GMP) regulatory agency inspections around the world. These independent and rigorous 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. 401 regulatory inspections of our manufacturing facilities † with no impact to licences 476 quality audits of our suppliers † In November 2019, CSL paid a civil penalty of US$4.7 million (RMB 33,488,050) for legacy (pre-acquisition) GMP non- compliances at CSL’s Ruide facility in Wuhan, China. We have remediated impacted processes, against CSL’s quality standard, to the satisfaction of local regulators. During the reporting period, CSL initiated two voluntary safety-related product recalls † . There were no recalls initiated by regulators. In January 2020, CSL Behring, Bern, Switzerland, initiated a recall on the Canada market for one batch of HIZENTRA pre-filled syringes due to the product appearing gelatinous. In March 2020, Seqirus, Parkville, Australia, initiated a product defect correction on the Australian market for one batch of PALEXIA due to faded and absent print on the blister foil. To assure continued consistent high-quality materials from our partners, CSL Behring and Seqirus conducted a combined 476 quality (GMP) audits of suppliers worldwide. Over the reporting period, there were 11 reported cases of counterfeit product; two of these were confirmed as counterfeit, five were CSL products, with the remaining four cases having limited data available or remaining 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. 50 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 50 pharmacovigilance (PV) audits: – 17 on internal systems and processes across our sites, including affiliates; and – 33 on third parties that undertake PV responsibilities on CSL’s behalf in various countries all over the world. * Limited assurance by Ernst & Young. † Does not include Ruide. Limited assurance by Ernst & Young. CSL Limited Annual Report 2020 37 9 A Trusted Health Partner