CSL Limited Annual Report 2021/22 51 In December 2021, CSL’s second, Board-approved, public Modern Slavery Statement under new Australian laws was published by the Australian regulator. To help minimise disruption to product manufacturing and supply, and to support our efforts to identify, remedy and ultimately prevent risks of instances of modern slavery occurring in our supply chain. CSL has joined the Pharmaceutical Supply Chain Initiative (PSCI) to collaborate with like-minded organisations across a number of social and environmental aspects including human rights and labour practices. We also continue to adapt our processes to assess and mitigate third party risk prior to onboarding. For existing suppliers we have commenced a process of communicating our expectations for business conduct by sharing (and in some case undertaking training on) our Third Party Code of Conduct, which was published in September 2021. Anyone with information about potential misconduct is encouraged to ‘Speak Up’ under the CSL Speak Up Policy. This includes all of CSL’s current and past employees, directors, contractors, customers, suppliers and associates. All reports made under this policy will be received and treated sensitively and seriously, and will be dealt with promptly, fairly and objectively. From 1 July 2021 to 30 June 2022, no reports related to human trafficking or slavery and forced labour in our global operations were received. You can read more on CSL’s modern slavery response in our 2021 Statement on CSL.com (Our Company > Corporate Responsibility > Key Publications). Health security A measure of the trust we have built is our position as a global leader in influenza pandemic preparedness and response. Thirty governments around the world rely on CSL Seqirus for pandemic influenza preparedness, including the US, the UK and Australia. CSL Seqirus also provides pandemic response commitments to the World Health Organization. Our government partners reserve pandemic vaccine doses from our facilities to protect their populations in the event of an influenza pandemic. CSL Seqirus also supplies pre-pandemic vaccine stockpiles that could be deployed to first-responders upon a declaration of an influenza pandemic. CSL Seqirus has three state-of-the-art manufacturing facilities on three different continents, together with a global fill and finish network located close to our end markets. CSL Seqirus passed two key milestones in the US in 2022. In February, CSL Seqirus renewed a multi-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The agreement provides influenza vaccines and adjuvants for pre-pandemic stockpiling or for manufacture to support rapid response to an influenza pandemic or other public health emergency. In June, CSL Seqirus announced that its manufacturing facility in Holly Springs, North Carolina, has successfully achieved all criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines as outlined by BARDA. With this recognition, the US Government confirms that CSL Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the US. CSL Seqirus’ adjuvanted egg-based pandemic and pre-pandemic vaccines have now been augmented, with the first ever adjuvanted cell-based pandemic vaccine, AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine). This vaccine is designed to help protect people six months of age and older against influenza A(H5N1) in the event of a pandemic and is approved for use by the US Food and Drug Administration (FDA). Construction work has also commenced on Seqirus’ new A$800+ million influenza vaccine manufacturing facility in Australia. The facility will utilise the same innovative cell-based technology used at our Holly Springs site, which has the potential for the rapid ramp-up of vaccine production in the event of a pandemic emergency. Access to our products Our products provide substantial and meaningful value to patients, healthcare providers, health insurance payers and healthcare systems around the world. We are proud of these contributions and seek to ensure that patients and communities have access to a reliable supply of biopharmaceuticals and vaccines. We work with governments, health insurance payers and other stakeholders to support timely and appropriate market entry and access, in order to enable appropriate patients to benefit from our therapies as quickly as possible. We value an ongoing dialogue with policymakers, advocacy groups, and other stakeholders to understand and respond to their needs and expectations. We articulate and communicate comprehensive evidence on the value of our innovations to inform access and reimbursement decisions, and we provide patient assistance programs and support advocacy efforts that improve access to care and affordability. In 2021/22, CSL’s investment for humanitarian access programs and product support initiatives totalled US$17.8 million.* In the US, access programs are critical to patients who are uninsured, underinsured or who cannot afford therapy. US$17.8 million supporting product access across the world* We are also committed to pricing practices that reflect the value our products bring to patients and society. To that end, we evaluate real-world and clinical trial data that demonstrate the clinical benefits our therapies deliver, as well as the cost savings they provide to overall healthcare. We also consider patient needs and preferences and how our therapies improve patients’ quality of life and productivity. * Limited assurance by Ernst & Young. Dollar value is a sub-set of CSL’s total community contributions.
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