CSL Ltd Annual Report 2020

None of these audits resulted in an outcome which affected our ability to supply product. Seqirus also underwent two successful regulatory pharmacovigilance inspections by the Therapeutic Goods Administration (TGA) and Paul-Ehrlich- Institut (PEI) in Australia and Germany, respectively. The safety of our donors, employees and the plasma we collect is of paramount importance. To ensure the continuous safety of the donors and the plasma supply, donors are carefully screened and tested for infectious diseases. Plasma and plasma products undergo rigorous quality controls and inspections throughout every step of the manufacturing process, from the collection of plasma to the final packaging of the finished product, to ensure that our plasma products are of the highest quality and safety. Plasma safety with COVID-19 The SARS-CoV-2 virus causing COVID-19 is large in size (approximately 120 nm in diameter). The relatively large size and lipid envelope makes it highly susceptible to steps with virus inactivation and removal capacity used during the manufacturing processes, such as pasteurisation, solvent-detergent (S/D) treatment, low pH incubation, dry-heat treatment, and virus filtration. The effectiveness of these processes has been demonstrated on other coronavirus lipid-enveloped model viruses that are quite similar to SARS-CoV-2, such as SARS-CoV, human coronavirus 229E and OC43, and porcine coronavirus TGEV. Based on these data, we can be assured that existing manufacturing processes will provide significant safety margins for our plasma products against SARS-CoV-2. New published data shows significantly reduced risk of haemolytic anaemia for patients receiving intravenous immunoglobulin Over the last several years, CSL Behring has identified and implemented changes to how we source plasma and manufacture intravenous immunoglobulin to help reduce the rate of haemolytic anaemia (HA). HA is a rare but potentially serious adverse event associated with all intravenous immunoglobulin therapies, occurring most often in people receiving high doses of the therapy. New data from two separate observational studies examining the effects of our adverse event mitigation efforts was published in the May and June issues of the journal Transfusion , the peer-reviewed journal of the AABB (formerly the American Association of Blood Banks), the professional membership organisation dedicated to advancing transfusion medicine and biotherapies. One study showed a 90% reduction in HA after changes made to the manufacturing process of PRIVIGEN, Immune Globulin Intravenous (Human), 10% Liquid, while another study confirmed these findings. These efforts, as demonstrated by this new data, will have long-lasting benefits for patients. The instances of HA have now become very rare with PRIVIGEN. Value and access CSL invests in programs to develop and supply innovative vaccines and therapies that protect public health, and extend the lives of people living with serious and rare diseases. The value our products provide to patients and society is meaningful and substantial. Our therapies save lives and improve clinical outcomes and quality of life, and our vaccines prevent life-threatening illnesses, each contributing to the reduction of overall healthcare costs around the world. We are proud of these contributions and work diligently to ensure that patients and communities have access to biopharmaceuticals. We work with governments, health insurance payers and other stakeholders to support timely market entry and access, as both play a critical role in the development of reimbursement frameworks and patient access regimes. 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. In 2019/20, CSL’s investment for humanitarian access programs and product support initiatives totalled US$6.56 million.* In the US, access programs are critical to patients who are uninsured, underinsured or who cannot afford therapy. US$6.56million 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 the improvements our therapies offer to improve patients’ quality of life and productivity. As a leader in our space, we are committed to dialogue with all interested stakeholders on how best to ensure continued patient access and affordability of medicines, and to preserve an ecosystem that sustains medical innovation for patients today and in the future. In 2019/20, there were no findings against CSL relating to a breach of any fair trading or competition laws. Public policy engagement CSL recognises the importance of participating in the formulation of public policies that can affect business operations, patient access to medicines, and the public health. To this end, we engage with governments directly and through participation in industry groups and other forums, and collaborate with a range of other interested stakeholders, including patient organisations, medical societies, and public health agencies at the global, national and local levels. Over the reporting period, CSL contributed a total of US$600 in corporate political contributions in the US and A$25,363 to political organisations in Australia solely for attendance at events including breakfast briefings, lunches or boardroom dinners. In all other regions, CSLmade no political contributions. * Limited assurance by Ernst & Young. CSL Limited Annual Report 2020 38 A Trusted Health Partner 9