The National Blood Authority (NBA) has had another very busy, challenging and rewarding year. We have continued to successfully manage the delivery of a safe, secure and affordable supply of blood, blood products and services for Australia.
The emergence of COVID-19 continues to challenge all of us personally, professionally and organisationally. The bushfires during the summer of 2019-20 also challenged aspects of our work and the continuity of the blood supply and, for many of us, also our personal and working lives. Like other organisations and their people, we have had to adapt to different ways of working and, in particular, how we can continue to engage most effectively with our very wide range of stakeholders, many of whom are understandably preoccupied with the immediacy of managing the health issues arising from COVID-19.
Our mission to save and improve the lives of all Australians remains unchanged. Our core business to manage the adequate safe, secure and affordable supply of blood and blood products remains our focus. We are continuously reviewing our contingency planning and working even more closely with the Australian Red Cross Lifeblood (Lifeblood) in relation to fresh blood and plasma supplies, with CSL Behring in relation to the fractionation of Australian plasma, and with our commercial suppliers in relation to imported products and associated supply chains.
Australia is currently in a good position for the availability of blood and blood products and we will continue to work hard to strengthen this position in the years ahead. This year, we have again worked closely with governments, patients, patient groups, clinicians, suppliers and others to achieve the best outcome possible within available funding for all Australians who need blood, blood products and services. Governments have spent almost $1.3 billion to achieve this outcome this year.
The clinical demand for blood and blood related products in Australia was met without interruption. There has been no requirement to activate the National Blood Supply Contingency Plan despite the risks to supply chains and logistics arising from COVID-19 and bushfires.
The NBA delivered savings during 2019-20 of $49.0 million against the annual budget approved and funded by all Australian governments. This brings the total amount of funding returned to governments over the last seven years to $673.8 million.
Improvements in supply performance and efficiency under the long-term Deed of Agreement for products and services provided by Lifeblood once again achieved a financial surplus to be returned to governments in 2019-20. This year, the surplus was approximately $31.7 million.
We have developed and rolled-out new and improved national systems to directly assist patients, clinicians and others to help manage and monitor health, supply and performance issues. We have accelerated the consideration of new blood products that have the potential to improve the health and quality of life for Australians with bleeding disorders. We have also continued with our work internally to improve the Agency's management systems, processes, governance and accountability arrangements.
There have been a number of other very important activities undertaken during 2019-20 that are highlighted in this Annual Report. In particular, the NBA has successfully concluded a tender process for the supply of standard half-life and extended half-life recombinant Factor VIII and Factor IX blood products. These products are critical for the treatment of Australian patients with bleeding disorders.
The outcome of this procurement gives Australian patients optimal access to products through nationally supplied and funded blood arrangements at very competitive prices. Australia imports these products through the NBA, as they are not made in Australia. The tender outcome is expected to deliver savings on product costs in the order of $155.8 million across five years, while continuing to ensure a safe and secure supply of these important treatments in Australia. The new arrangements commence on 1 July 2020 for a period of up to five years.
The safe, secure and affordable supply of blood and blood products in Australia is influenced by both the domestic and international context, including global developments and issues. The NBA has therefore maintained active international engagement activities since its inception in 2003 and also maintains active horizon scanning across the blood sector. These activities reflect the importance of understanding and influencing global issues, understanding commercial networks and markets in the blood sector, building and maintaining networks and intelligence across the sector, setting and influencing strategic directions where we can, and obtaining the best possible prices and contracts for products on behalf of governments. The engagement includes participation in both domestic and international bilateral and multi-lateral meetings, discussions, conferences and other forums involving patients, patient groups, clinicians, suppliers, governments and others.
While our engagement in these forums has been curtailed during 2019-20 due to travel restrictions arising from COVID-19, the information and intelligence the NBA gathers from participating in a global market for the supply of blood products remains vitally important. This is even more so during current challenging times, and the NBA has therefore continued to maintain a close watch of relevant issues and worked even more closely with our partners, stakeholders and suppliers to ensure Australia remains in a strong and secure position.
The NBA completed a significant project during 2019-20, with a major review of the efficiency of Lifeblood being finalised. The NBA engaged Pricewaterhouse Coopers Consulting (Australia) Pty Ltd (PwC) to assist with this review. PwC consulted with key stakeholders and considered a number of factors to objectively assess Lifeblood’s efficiency, noting it is a sole supplier of fresh blood and plasma in Australia. This included the efficiency of Lifeblood’s end to end supply chain; comparisons with similar commercial manufacturing and processing operations; interconnected factors that governments could consider in making decisions on the future path for domestic plasma supply; and opportunities for improvements and efficiencies. Overall, the review found that Lifeblood is efficient and delivering value for money to governments. This is a great credit to Lifeblood as well as to the very effective partnership between Lifeblood and the NBA.
The findings of the review will also inform future decisions to be made by governments regarding the implementation of policy objectives, including domestic plasma collection levels and the potential for Lifeblood to increase plasma supply. This is even more important in the context of potential domestic sovereignty issues arising from COVID-19, supply security more generally, and budgets going forward. The NBA and governments will finalise consideration of domestic plasma collection levels in 2020-21.
The NBA has ensured uninterrupted supply of immunoglobulin (Ig) products in Australia since 2004. The continuous and increasing demand for Ig has presented challenges for secure supply and affordability. These challenges have been met through the National Immunoglobulin Governance Program, supported by the national implementation of the NBA’s BloodSTAR system, which provides the sole channel for clinicians to seek authorisation for access to Ig products, and the revised Criteria for the clinical use of intravenous immunoglobulin in Australia (Version 3 of the Criteria).
The program is the first of its kind in the world, bringing together a number of disparate processes with new approaches to improve the use of high cost Ig products made from blood plasma.
I am very pleased to note that the National Blood Authority received three prestigious awards in recognition of the work of the National Immunoglobulin Governance Program, including the Prime Minister’s 2019 Silver Award for Public Sector Excellence. These awards acknowledge the work of NBA staff in collaboration with a diverse group of stakeholders to develop improved arrangements for the appropriate use of this precious and costly blood product.
The NBA Advisory Board was regularly updated by the NBA during 2019-20 on progress against strategic and operational plans, and the Board provided advice and guidance to inform the development of future programs and plans. In August 2019 Lifeblood hosted the Joint Board Meeting between the two organisations at its headquarters in Melbourne. This annual joint meeting provides for valuable strategic and informative discussions at Board level that support the work of the individual organisations and strengthens the partnership and relationship enormously. Members of the NBA Board, with officers from the Department of Health and the NBA, also visited the substantial Lifeblood Processing Centre in Melbourne as well as the CSL Behring Australia Base Fractionation Facility at Broadmeadows.
Ms Roslyn Jackson was appointed as the Chair of the NBA Audit and Risk Committee (ARC) in September 2019 following the resignation of Mr Ken Barker from the committee. Ms Jackson has been a member of the committee since September 2017. The NBA farewelled and thanked Mr Barker for his valued input as Chair of the ARC and his many years of collaboration with the NBA. Mr Barker was appointed to the NBA Interim Board in 2003 and served as a full Board member until 2013. He has been a member of the ARC since its inception in 2003, which included three terms as Chair.
The NBA’s research and development grants program continued with Round 4 funding finalised that provided grants in early 2019-20 to address evidence gaps in patient blood management and funding for research relating to Immunoglobulin issues. The NBA R&D program will continue, with the assessment of Round 5 grant applications being finalised towards the end of 2020, and decisions to be made in the first part of 2021. New and growing work is also emerging with the NBA’s increased involvement with health technology assessments and processes for new products and reviewing the utilisation of existing products.
In November 2019, the Medical Services Advisory Committee (MSAC) considered an application relating to the supply of replacement Ig for the treatment of acquired hypogammaglobulinaemia secondary to haematological malignancies or post-haemopoietic stem cell transplantation. This is the first of the Ig medical conditions to have had this assessment process completed. Through a public summary document, MSAC advised that no immediate changes were required to the eligibility criteria, but that there should be more research to determine the specific patient groups and best-practice Ig use for greatest benefit. The NBA will consider the MSAC’s recommendations from this and subsequent reviews, as well as performing a review of international eligibility criteria to inform future Ig Criteria updates.
The NBA made significant progress in the review of the national guidelines for the use of Anti-D immunoglobulin, in continuing the complex review and update of the suite of Patient Blood Management (PBM) Guidelines, and in continuing the PBM implementation and wastage reduction programs. The NBA is exploring increased international collaboration with its world leading PBM arrangements. Governments continued funding of $1 million annually in 2019-20 for the BloodSAFE eLearning Australia (BEA) program to continue relevant clinical education. BEA received 59,935 new user registrations in 2019-20 and, by June 2020, it had 599,226 learners registered who had completed 1,350,501 courses. This equates to more than 2.1 million hours of education with courses provided without charge to participants and a suite of short videos being available to participants.
The NBA continued to make critical contributions to the revision of the National Quality and Safety Health Service Standards, including by ensuring the continuation of the Blood Management Standard, and with the development of supporting materials for implementation. There has also been substantial work to refresh the Haemovigilance Advisory Committee and its important work in supporting the national haemovigilance program, including the collection, analysis and publication of national haemovigilance data.
Maintaining effective relationships and communication with all stakeholders and interests is a vital part of the NBA’s work and a key challenge for a small Agency in the time and effort required to achieve proper engagement. This became more challenging in the second part of 2019-20 but we continued to meet virtually and share information with patient and clinical representative groups and individuals, with supplier partners and prospective suppliers, with professional bodies and many others.
I would like to once again recognise the very substantial contributions that many of our stakeholders across the blood sector make through generously giving their time, expertise, professionalism and passion to work on some very important issues with the NBA during the year. We look forward to working with you again in 2020-21.
I would also like to thank my executive management group for their ongoing support, commitment and dedication, and also thank the NBA Advisory Board for the very strong support and advice it has provided throughout the year. I want to conclude by giving a very special thank you to all of the staff of the NBA who have had to really step-up to continue to seamlessly deliver the national blood arrangements at such a high standard in the face of such enormous challenges to Australia during 2019-20. It has been a great pleasure to lead the organisation with such strength, commitment and professionalism behind me during this period.