CSL Ltd Annual Report 2019

At a global level, Seqirus continues to be an active member of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), with the focus this year on supporting greater understanding amongst the public health community of the impact of the Nagoya Protocol on the access and benefit sharing of influenza viruses. Seqirus has also worked with the World Health Organization (WHO) to enhance policies to support capacity-building for seasonal influenza vaccination and pandemic preparedness. Additionally, we have supported projects to advance a life- course approach to vaccination and to raise awareness of the role of vaccines in preventing anti-microbial resistance. Secure and reliable supply Our investment in innovative products and reliable supply is critical to achieving access to lifesaving and life-enhancing medicines. Responsible pricing is key to maintaining our research and development pipeline. We continue to invest heavily in advanced manufacturing in key global locations, to support reliable and responsive supply (see page 22 for more). CSL Plasma is the world leader in plasma collection and achieved a record year in centre openings with 30 over the reporting period, taking the global fleet above 235. While these up-front investments take time to yield products for patients, they are critical to ensuring the strong demand for our products can be delivered without interruption. In 2018/19, CSL Plasma also acquired a liquid saline and sodium citrate facility in South Carolina, US, to support its vast plasma collection network. CSL remains compliant with all product serialisation regulations having achieved implementation milestones in Europe in 2018/19 and preparing for regulations in various other countries. Pandemic and emergency response A measure of the trust we have built is our position as a global leader in pandemic preparedness and response. 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. Our facility in the US, built in a partnership with the US Government, is unique as it utilises cell-based technology for influenza vaccine production which has the potential for the rapid ramp up of pandemic vaccine production. Each Seqirus facility provides pandemic response solutions to its host country, to WHO and to a number of nations willing to reserve pandemic vaccine doses to protect their populations in the event of an influenza pandemic. In addition, several governments have entered into agreements with Seqirus to procure pre-pandemic vaccine stockpiles that could be deployed to first-responders upon a declaration of a pandemic. During the reporting period, Seqirus entered 16 new pandemic vaccine agreements with governments in the America and Europe regions. We also submitted a biological license application to the US FDA for an MF59-adjuvanted cell-based pandemic (H5N1) vaccine produced at our Holly Springs facility. As part of our contribution to protect public health worldwide, Seqirus continued its support for the Pandemic Influenza Preparedness Framework operated by WHO, which aims to build pandemic preparedness capacity in low and middle- income countries. This year, Seqirus has joined the Private Sector Roundtable (PSRT), a coalition of companies that acts as a central touchpoint for industry engagement to support countries in achieving the goals of the Global Health Security Agenda (GHSA). As a core member on the PSRT Steering Committee, Seqirus aims to contribute to addressing global health security challenges and, in particular, explore ways to help countries become more resilient to pandemic influenza threats. Relationships with healthcare professionals, regulators and patient groups We have strong and deep relationships with key stakeholders across the sector including healthcare professionals, regulators, patient and clinical groups. These ties are an important part of the social capital that adds value to our business. CSL patient focus requires a commitment to working with a broad set of healthcare professionals including regulators to help patient groups and CSL advance collective expertise across our therapy areas. We actively collaborate with patient organisations to help fulfill their mission of building patient communities, increasing knowledge awareness and diagnosis of conditions. In 2018, CSL launched a new initiative to look at how we translate our strong patient-focused culture into our work, helping us better define what it means to be a patient- focused organisation in today’s changing healthcare environment. Employees from across the organisation are exploring how CSL can ensure that working with patients and for patients is embedded across our diverse operations. Participants are advancing practical opportunities to co- create with our patients throughout the product lifecycle; for example, deeper consultation with patients on clinical trial design and understanding the unmet need from the patients’ perspective. Working in defined streams and leveraging leading practice, the ideas and focus areas will be explored more deeply for implementation across the organisation to ensure CSL continues to deliver on its promise to patients. Responsible marketing and promotion Responsible marketing of prescription medicines is vital to maintaining consumer trust and ensuring patients receive the maximum benefits from our products and services. Government regulation and industry codes oversee the marketing of our medicines across key regions where we operate. CSL recognises that reputation in the marketplace and success as a reliable supplier of biopharmaceuticals relies on ensuring our medicines are honestly represented in our interactions with healthcare professionals, consumers and other customers. Promotional Review Committees, comprising cross-functional members, operate across CSL business units to ensure compliance with all applicable local laws, regulations and accepted industry codes, such as Medicines Australia Code of Conduct (MA Code) and the European Federation of Pharmaceutical Industries and Associations Code for European Union member countries. The committees are responsible for ensuring information on medicines, vaccines and therapy areas is balanced, supported by scientifically valid data and compliant with relevant laws and codes. CSL Limited Annual Report 2019 29