- Nuclear Medicine Facility project
Australian Nuclear Science and Technology Organisation
2.1The Australian Nuclear Science and Technology Organisation (ANSTO) seeks approval from the Committee to proceed with its proposed Nuclear Medicine Facility project at its Lucas Heights campus in New South Wales.
2.2Since the late 1970s ANSTO has produced a variety of nuclear medicines, supported scientific nuclear research and advised the government on nuclear matters. It is mandated to produce nuclear medicines for the health of Australia and currently supplies 75 – 80 per cent of all nuclear medicine used in Australia, enabling between 10,000 and 12,000 procedures each week.[1] This project will secure Australia’s access to a long-term supply of vital nuclear medicines, including those used to diagnose and treat cancer.
2.3The proposed facility will replace ANSTO’s existing nuclear medicine facility (also known as Building 23) with a new two-storey nuclear medicine manufacturing facility, positioned on a vacant lot of land adjacent to the OPAL research reactor and the Mo-99 Manufacturing Facility at Lucas Heights.
2.4Building 23 was established in 1959 and is not well-suited for the safe and reliable manufacture of nuclear medicine products over the medium to long-term. To ensure a sustained supply of nuclear medicine, Building 23 will remain operational until the new facility is built and operational in the mid-2030s.
2.5The estimated cost of delivery of the project is $619.23 million (excluding GST).
2.6The project was referred to the Committee on 15 November 2023.
Conduct of the inquiry
2.7Following referral, the inquiry was publicised on the Committee’s website and via media release.
2.8The Committee received two submissions and one confidential submission. A list of submissions is at Appendix A.
2.9On 2 April 2024, the Committee conducted a site inspection at ANSTO’s Lucas Heights campus, followed by a public and in-camera hearing in Yarrawarrah, New South Wales. A transcript of the public hearing is available on the Committee’s website.
Need for the works
Background
2.10ANSTO’s Lucas Heights campus is home to a nuclear medicine precinct with three key facilities: the Opal multipurpose research reactor, the molybdenum-99 manufacturing facility and the existing nuclear medicine processing and distribution facility (Building 23).
2.11The purpose of Building 23 is to prepare nuclear medicines for dispatch, providing Australia with vital sovereign manufacturing capabilities in nuclear medicine products.
2.12ANSTO’s current products include the radioisotopes technetium, lutetium and iodine, producing around 75 – 80 per cent of the nuclear medicine isotopes used in Australia. This enables over 700,000 patient procedures each year, making the facility vital to Australia’s healthcare sector.
2.13At the public hearing Mr Shaun Jenkinson, Chief Executive Officer of ANSTO stated:
On average, every Australian is likely to benefit from nuclear medicine and will require at least two doses or two procedures during their lifetime. Each week ANSTO produces nuclear medicine to enable between 10,000 and 12,000 procedures in Australian hospitals, medical centres and clinics.
Existing facility replacement
2.14Building 23 was initially constructed in 1959 as a research laboratory and is approaching the end of its useful life. A 2016 feasibility study concluded that the facility was not fit to continue producing nuclear medicine beyond the medium-term and that it would not be possible to refurbish the facility. Industry regulators such as the Therapeutic Goods Administration, the Auditor General and the Australian Radiation Protection and Nuclear Safety Agency have since corroborated these findings.
2.15To ensure a sustained supply of nuclear medicine, Building 23 will remain operational until the new facility is completed in the mid-2030s.
2.16At the public hearing, ANSTO discussed the importance of the new facility having additional space for future production of emerging nuclear medicine products:
The new nuclear medicine facility will form a more sophisticated nuclear medicine precinct to enable a seamless manufacturing and distribution chain. It will ensure that ANSTO has the flexibility to adapt to evolving manufacturing technologies and meet the challenging needs of the radiopharmaceutical markets, particularly as cancer and other illnesses and diagnosis rates continue to grow in our community.
2.17Specific spatial requirements for the new facility include the ability to manufacture:
- Technetium: Production of between 200 and 400 generators per week to reliably meet local needs and provide an ability to export surplus product / capacity.
- Lutetium: Production capacity of 20TBq1 per week in order to meet the expected demand from growing export markets.
- Iodine: Production capacity of 25TBq per week which is in line with the current arrangements.
- At the public hearing ANSTO discussed additional design requirements for the new facility:
The new-design facility has greater capacity than the existing facility, so this will enable us to deal with any increase in domestic demand. Plus, the redundancy capability in there means that we will be able to support the Asia-Pacific region more broadly as required.
When we were putting the business case together for this facility we looked at what the current capability of the older facility is. We looked at market growth, the ageing population, the population density of Australia, and what that looks like into the future. We've planned for up to 400 technetium generators a week and up to 20 TBq of lutetium a week, and I think it was 25 TBq of iodine. They are quite large numbers, so there is more than enough capacity in the new facility, across its life, to meet future needs. There is also the extra capacity that we built in for new and emerging products, so that can change throughout the life cycle of the facility. As part of the way we've designed the facility, we can introduce new processes and technologies while we continue to operate the facility. We've set aside manufacturing areas, separate to the maintenance corridors, which allows us to rejig the whole facility depending on what we're going to manufacture.
2.19At the public hearing Mr Mark Moore, Engineering and Technical Director, Nuclear Medicine Manufacturing Facility, ANSTO explained that the new facility will require skill enhancement and retraining of staff:
A lot of the people that are currently working in Building 23, the current manufacturing facility, will need to get some enhanced skills and be retrained in some aspects, so they may now have a role that's very manual, hands-on manufacturing, but we foresee that, in the new facility, it'll be a lot more automated. So we'll need to see more of a calibration and maintainer role coming out of that in order to keep the equipment running and operational.
Options considered
2.20ANSTO developed the following three options to meet project requirements:
- Option 1 – Replacement of domestic manufacturing facility – core products: this option involves the construction and replacement of ANSTO’s domestic manufacturing facility with a facility that has the capability to provide core nuclear medicine products. This option will minimise the risks of domestic patients not having access to vital products.
- Option 2 – Replacement of domestic manufacturing facility – technetium only: this option involves the construction of a smaller facility which will produce technetium only, with the remaining products to be imported. This option will create a ‘risk, albeit small’ that the remaining products would not be available to domestic patients.
- Option 3 – Import only – all products: this option involves ANSTO moving to an importation model for all nuclear medicine products, however this would create a higher risk to domestic access to nuclear medicines and would also involve a higher overall cost.
- ANSTO notes that retrofitting options of the existing facility at Lucas Heights were not considered ‘because they would fail to meet the regulatory requirements in relation to safety’ and good manufacturing practice. This is consistent with the findings from the 2016 feasibility study which found the existing building could not be refurbished.
- The preferred option for the project is Option 1. This option delivers the best value for money and provides the most reliable access for domestic use. ANSTO notes this option is also consistent with Commonwealth objectives:
The preferred option is also consistent with the sector objectives in the most recent Commonwealth Budget – i.e. to develop key medicines locally and to rebuild Australia’s industrial base. Medical science is considered one of the seven priority areas to revitalise industry and build economic resilience.
Scope of the works
2.23The proposed replacement nuclear medicine facility will be constructed at ANSTO’s Lucas Height Campus, Sydney, NSW on land adjacent to the OPAL nuclear reactor and other buildings that supply active ingredients for nuclear medicine products.
2.24The facility will be a two-storey building with a site footprint of approximately 6,500m2, a gross floor area of 12,700m2, and an additional 3,000m2 of walkable space above the ceiling of the ground floor for maintenance access.
2.25The following is a breakdown of the gross floor area:
- Basement (4,250m2): this level is where materials will enter and exit the facility. As quantities of active materials, including waste, will be stored on this level, it will be isolated from other functions of the building. Materials will be moved from the basement to the ground floor via lifts and ‘dumb waiters’.
- Ground floor (6,200m2): this level will be dedicated to the production of nuclear medicine with the inclusion of production manufacturing suites, quality assurance spaces and offices.
- Rooftop (2,250m2): some plant functions will be housed on this level with the inclusion of lift and stair access for the movement of equipment and materials. Photovoltaics are also planned for the rooftop level space.
- The new facility will have an anticipated design life of 50 years and include:
- Warehouse – raw material: primarily to be used for the receipt of incoming materials, including active and non-active materials.
- Waste area: to be used for the preparation of non-active waste materials for disposal and the storage and treatment of active materials until they are safe to be disposed.
- Warehouse – dispatch: to be used for final packaging and shipment of all items.
- Production preparation: to be used for the preparation of equipment and chemicals prior to entering the production suites. The space will also handle decontamination of some equipment.
- Maintenance area: the area will be used to support the production areas by repairing and maintaining equipment and storing parts and equipment.
- Plant room: will contain large scale major utilities for the building. The majority will be located in the basement, while some will be located on the rooftop level and some outside the building footprint.
- Production suite technetium: the purpose of this area is to produce a generator device for extraction of technetium from the molybdenum solution that is received from the ANSTO nuclear medicine facility. The new generator device and production lines will provide a catalyst for a new technetium generator design that can improve the reliability of supply.
- Production suite tellurium based iodine: this area will cover the manufacturing of tellurium-based iodine 131 (I-131 tellurium-based). The new facilities production area will be designed to provide higher levels of reliability and capacity than the current facility. ANSTO note that tellurium currently produced at Lucas Heights is of higher quality and value compared to overseas products.
- Production suite lutetium: this area will be composed of the main Grade C production space, with an adjacent technical space with access to the back of the hot cells.
- Aseptic suites (contract manufacturing use): this room will have a range of capabilities. ANSTO anticipates future contract manufacturing of niche / innovative alpha and beta emitting therapeutic products.
- Development suite: this suite will support the development of new nuclear medicine, radioisotope production and radioactive medical device products, within a good manufacturing practice environment for phase 1 clinical trials.
- Generator development suite: to be used for the manufacture of future medical device radioisotope generators of similar configuration to technetium.
- Production spaces (non-active): to be used for testing of non-radioactive materials and keeping records for quality control purposes.
- Quality control spaces (active): to be used for testing of radioactive products and batch managed materials against specifications.
- Personnel support: to be used for gowning in the facility and clean change prior to entering production spaces.
- Office space: the primary working location for most of the staff in the building.
- ANSTO anticipates that the new facility will be commissioned and operational in the mid-2030s. The existing facility will be maintained until that point to ensure that ANSTO can continue to supply nuclear medicine.
- At the completion of the new facility, Building 23 will be decommissioned and demolished. This process will be funded separately through an approved 40-year decommissioning fund. The contained hot cells and other specialist infrastructure require careful management and a cool down period to manage the radioactivity within the building prior to demolishing.
- At the public hearing ANSTO further elaborated on the process required for safely decommissioning Building 23:
There will be some aspects of the old facility that will need to be dealt with as part of decommissioning. There are some longer lived isotopes that will be allowed to decay during the decommissioning. Some things can be cleaned. A lot of it will go to free waste, so it can be taken offsite, but there will be certain aspects that will need to be held by ANSTO, such as the internal containment vessels that may have radioactive contamination.
2.30The project will include additional demolition works such as the demolition of the eastern extension of Mendeleeff Avenue and the adjacent accessible parking area, the existing Aston Avenue between Mendeleeff Avenue and Rutherford Avenue, and seven buildings within the project’s footprint which have been deemed end of life.
2.31The scope of works also includes the construction of a new road to connect Mendeleeff to Bragg Avenue, which will provide north to south access through the reactor precinct.
Community and stakeholder consultation
2.32ANSTO’s Stakeholder and Communication Management plan identified the following project stakeholders:
- The Minister for Industry Science and Resources – The Hon Ed Husic MP
- Various Commonwealth departments
- Various New South Wales State departments.
- Regulators and industry bodies
- Neighbours and community
- Nuclear Medicine Customers and Suppliers.
- Forms of engagement with ANSTO’s stakeholders have included meetings, briefings, preliminary verbal advice and presentations. ANSTO will continue to engage with specific stakeholder groups throughout the next phase of the project.
Cost of the works
2.34The estimated total capital delivery cost of the project is $619.23 million (excluding Goods and Services Tax). This includes construction costs, management and design fees, furniture, fittings and equipment, contingencies and escalation allowance.
2.35ANSTO provided further details on project costs in its confidential submission and during an in-camera hearing.
Revenue
2.36ANSTO anticipates that the new facility will generate a significant yearly revenue, however the facility is not forecasted to fully recoup all construction, finance and operational costs over the next 40 years.
Public value
2.37ANSTO’s Lucas Height’s campus is unique in the world for its co-location of the reactor, the molybdenum-99 manufacturing facility and the nuclear medicine manufacturing facility. This enables Australia to ensure its sovereign supply at a domestic level without the additional complexity of sourcing irradiated material from multiple reactors.
2.38The larger replacement facility will enable ANSTO to cater for the forecast increased demand for nuclear medicine in Australia based on population growth. The new facility has been designed to accommodate the production of any new and emerging products which ANSTO may be required to produce during the lifetime of the new facility.
2.39ANSTO also considers that investment in the nuclear medicine sector has a range of economic benefits, citing projected shortages in nuclear imaging and medicine capability worldwide. In its submission, ANSTO states that investment in the nuclear medicine sector has broad socio-economic benefits to industry, health care professionals, and patients.
Auditor-General Report No.26 2021–22
2.40The Auditor-General Report No. 26 of 2021–22, Australian Nuclear Science and Technology Organisation’s Management of Nuclear Medicine Assets, assessed the effectiveness of ANSTO’s management of assets involved in the manufacture, production and distribution of nuclear medicines.
2.41The report found that:
- ANSTO’s management of nuclear medicine assets is partly effective
- ANSTO’s asset management framework is largely fit-for-purpose
- Planning and implementation of asset acquisition and disposal is partly effective
- Maintenance practices for the nuclear medicine assets are developing
- ANSTO’s measurement and monitoring of asset performance is partly effective.
- At the public hearing ANSTO discussed the findings of the Auditor-General Report:
We updated and brought our governance oversight of programs to align with approved ISO standards for program delivery. We have ensured we have appropriate people engaged, such as Adele Eagleton as the program director. We have a very structured governance process now. We report back to our CEO, our board and government. We have established a steering committee to this project, which has been running since the start of the business case development. That steering committee consists of internal people and externals, including DISR representatives, as well as ANSTO board members. We report concisely on both progress on time and progress on cost.
Committee comment
2.43It is important that Australia has a secure supply of nuclear medicine products. Australia’s ability to manufacture nuclear medicine products for domestic use is dependent on the ANSTO facilities at Lucas Heights. The Committee appreciates the vital work of ANSTO and acknowledges the commitment shown by ANSTO staff.
2.44The Committee was pleased to note the focus on the export potential of nuclear medicine into the Asia-Pacific region, from both an economic and humanitarian perspective. It is clear that this area is continually evolving as new medical technologies develop. The new facility will continue to provide research facilities into emerging nuclear medicine technology.
2.45The Committee did not identify any issues or concerns with the proposal, and it is satisfied that the project has merit in terms of need, scope and cost.
2.46The Committee notes the ongoing question of nuclear waste, and re-iterates the importance of a purpose-built facility for the storage and disposal of low-level and intermediate-level nuclear waste in Australia.
2.47Having regard to its role and responsibilities contained in the Public Works Committee Act 1969, the Committee is of the view that this project signifies value for money for the Commonwealth and constitutes a project which is fit-for-purpose, having regard to the established need.
2.48The Committee recommends that the House of Representatives resolve, pursuant to section 18(7) of the Public Works Committee Act 1969, that it is expedient to carry out the following proposed works: Australian Nuclear Science and Technology Organisation — Nuclear Medicine Facility project.
2.49Proponent entities must notify the Committee of any changes to the project, scope, time, cost, function, or design. The Committee also requires that a post-implementation report be provided within three months of project completion. A report template can be found on the Committee’s website.
Mr Graham PerrettMP
Chair