CSL Ltd Annual Report 2020

At a global level, Seqirus continues to play an active role within the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). This year, the focus is on supporting greater understanding amongst the public health community of the impact of the Nagoya Protocol, and other national legislation related to the Convention on Biodiversity, on the access and benefits of the sharing of influenza viruses. Seqirus also continues to work 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 antimicrobial resistance and to explore innovative partnership solutions to vaccine hesitancy. Influenza pandemic and emergency response A measure of the trust we have built is our position as a global leader in influenza 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 and WHO. There are agreements in place with a number of other nations willing to reserve pandemic vaccine doses to protect their populations in the event of an influenza pandemic. In addition, Seqirus supplies pre-pandemic vaccine stockpiles that could be deployed to first-responders upon a declaration of an influenza pandemic. During the reporting period, Seqirus renewed two influenza pandemic vaccine agreements with governments in Europe. In January 2020, the Food & Drug Association (FDA) approved a biological license application for an MF59 ® -adjuvanted cell-based pandemic (H5N1) vaccine AUDENZ™ 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. Seqirus is active in 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 patient groups We have strong and deep relationships with key stakeholders across the sector including healthcare professionals, regulators, patients and clinical groups. These ties are an important part of the social capital that adds value to our business. CSL’s commitment to patient focus continues to be emphasised at a global and local level. We continue to find mutually beneficial ways to partner with patient stakeholders to address community needs and advance collective expertise and thinking across our therapeutic areas. In 2019, cross-functional teams across CSL businesses and regions came together to initiate pilot patient engagements in new areas. Two notable examples are the Sjogren’s Syndrome Early Research Patient Experience Mapping in Australia and the Alpha 1 Antitrypsin Lifecycle Management Patient and Caregiver Workshop in Germany. The Sjogren’s Advisory Board aimed to understand what patients would define as a meaningful treatment outcome and how they would prioritise several of the condition’s quality of life altering impacts (physical, emotional, and financial). These insights were gathered into actionable learnings to inform potential research programs and to guide future engagements with patients in early research. The Alpha 1 Antitrypsin Workshop aimed to enhance CSL’s understanding of factors that impacted self-administration. Learnings translated into ways to increase awareness and education and to enhance user experience, including revisions to CSL packaging design guidelines incorporating the patient perspective. CSL continues to work on developing methods and processes for periodically and consistently engaging with patient stakeholders at key points in the development continuum, thereby ensuring CSL will continue 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. During 2019/20, promotional materials for Seqirus Australia’s inactivated influenza vaccine adjuvanted, FLUAD, distributed between March and April 2019 were found to be in moderate contravention of some terms of the Medicines Australia (MA) Code of Conduct. The MA Code panel found that the promotional materials included claims about clinical efficacy that were not consistent with the FLUAD-approved product information, and Seqirus was fined A$80,000. The promotional material included the term ‘immune response’ as a proxy for clinical efficacy. While immune response is the standard used in the regulatory approval of vaccines, the panel found that immune response is insufficient evidence to support claims for the degree, breadth or duration of clinical effect. Being committed to the highest ethical standards, Seqirus agreed to publish a corrective letter to healthcare professionals. CSL Behring Australia, CSL’s other major commercial entity in Australia, was not found to be in breach by the MA. In Canada, an unbranded email campaign to healthcare professionals in October 2019 was found by the Pharmaceutical Advisory Advertising Board (PAAB), an independent agency providing a pre-clearance review service of medical promotional material, to be in contravention of some terms of the PAAB Code of Advertising Acceptance and some federal regulations. The PAAB ruled the unbranded material included implied promotional claims attributable to Seqirus and that the claims lacked sufficient substantiation. Seqirus agreed to not use the material in any future campaigns unless it was amended in accordance with the PAABs suggestions and pre-clearance. No fine was issued and no further regulatory action took place. Though not required by law, Seqirus agreed to submit all promotional material to the PAAB for pre- clearance in the future. CSL Limited Annual Report 2020 40 A Trusted Health Partner 9