CSL Ltd Annual Report 2021

Examples of public policy initiatives across our regions Asia CSL continues to work with stakeholders in China to explore ways for rare disease patients to gain broader access to treatments as part of the Greater Bay Area healthcare initiative. Australia CSL worked closely with the Australian biotech and medtech sectors to promote the introduction of an Australian ‘patent box’ model to incentivise the onshore commercialisation of medical research. As Australia’s only onshore vaccine manufacturer, CSL was critical to the Australian Government’s response to COVID-19, agreeing to retool our facilities in order to manufacture 50 million doses of the AstraZeneca viral vector vaccine for Australia and our Pacific Island neighbours. Europe In Europe, CSL Behring continued to lead industry and independent policy engagement at the European level in relation to the European Blood Directive and the European Pharmaceutical Strategy. North America CSL has undertaken a number of public affairs and policy initiatives in the US and Europe to prepare for the potential launch of EtranaDez, a gene therapy treatment for haemophilia B. These include engaging with governmental authorities to advocate our perspective on the appropriate payment frameworks for gene therapies, and becoming an active participant in multi-stakeholder forums such as the Alliance for Regenerative Medicine, Rare Impact Initiative and the European Alliance for Transformative Therapies. Working independently and in partnership with the broader plasma protein therapies (PPT) industry and patient communities, CSL worked with the US government to ensure that PPTs are available to patients and reimbursed appropriately in a number of areas under the US Medicare program. This included the adoption of an exclusion for Ig from the prior administration’s international price referencing proposal, and the permanent extension of an administrative payment for HIZENTRA ® when administered through durablemedical equipment. CSL Behring worked with federal, state, and local officials in the US to ensure safe and adequate plasma collection capacity in the context of the COVID-19 pandemic. This included ensuring appropriate application of state and local COVID-19 occupancy and social distancing rules. Building on the 2019 Executive Order (EO) 13887 on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health, the National Influenza Vaccine Modernization Strategy (NIVMS) outlines a vision for the United States’ influenza vaccine enterprise to be highly responsive, flexible, resilient, scalable and more effective at reducing the impact of seasonal and pandemic influenza viruses. This vision is supported by three overarching strategic objectives: 1 strengthen and diversify influenza vaccine development, manufacturing, and supply chain; 2 promote innovative approaches and use of new technologies to detect, prevent, and respond to influenza; and 3 increase influenza vaccine access and coverage across all populations. Seqirus has been engaged with the US Department of Health and Human Services (HHS) task force driving the NIVMS, providing input directly and through stakeholder groups and trade associations to ensure that the strategy is feasible and achievable. The strategy supports promotion of new vaccine technologies, such as cell-based manufacture, towards reducing US reliance on egg-based manufacture. 9 A TrustedHealth Partner CSL Limited Annual Report 2020/21 46