Online version of the 2014-15 Department of Health Annual Report

Outcome 7: Health Infrastructure, Regulation, Safety and Quality

Improved capacity, quality and safety of Australia’s health care system to meet current and future health needs including through investment in health infrastructure, regulation, international health policy engagement, research into health care, and support for blood and organ donation services

Page last updated: 17 July 2019

Major Achievements

  • Supported the Australian Commission on Safety and Quality in Health Care, in partnership with the Australian Institute of Health and Welfare (AIHW), to lead Australia’s contribution to an Organisation for Economic Co-operation and Development (OECD) study on variations in medical practice. This landmark study examined variation in rates of several common procedures, such as knee surgery. Results will help ensure the community is able to make informed decisions about their own health care.
  • Made significant progress towards a collaborative national approach to improving clinical trials in Australia, through the Department’s membership of the Clinical Trials Advisory Committee and the Clinical Trials Jurisdictional Working Group (CTJWG).
  • Promoted the Personally Controlled Electronic Health Record (PCEHR), and over 2.2 million consumers have registered.
  • Made a prominent contribution to the global health agenda, including on communicable disease control and outbreak response, providing support for the World Health Organization (WHO)’s efforts in responding to the Ebola Virus Disease crisis in West Africa, strengthening WHO’s emergency preparedness and response capacity, and in leadership on international medicines and medical devices regulatory collaboration.
  • Completed the pilot phase of the electronic Common Technical Document (eCTD) for regulatory approval of over-the-counter and prescription medicines. The eCTD will improve the efficiency of the application process and potentially reduce the time taken for new medicines to become available to the Australian public.


  • Implementing changes to the legislation, the system, and the engagement with stakeholders are all required to support the implementation of the Australian Commission for eHealth and the operation of the opt-out participation trials, which will require public consultation and agreement with the States and Territories in very tight timeframes.

Looking Ahead

In 2015-16, the Department will continue to ensure that implementation of changes to the PCEHR are informed by consultation with industry, the community and State and Territory Governments. The Department will build on the gains made to date in the evidence-based prescription drug programme and appropriate use of blood and blood products in Australian hospitals, with the aim of further reducing inappropriate wastage. The Department will support the Australian Medical Research Advisory Board to develop the Australian Medical Research and Innovation Strategy and Priorities and disburse the first funds of $10 million from the Medical Research Future Fund (MRFF). The Department will work with the NPS MedicineWise to continue to develop and implement programmes which will improve the quality use of medicines, in support of Australia’s National Medicines Policy.

The Department will provide advice to Government on the reforms proposed by the Expert Review of Medicines and Medical Devices Regulation, and implement those reforms agreed by Government. The Department will implement the reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced in the 2015 Budget. The Department will also implement the four priority areas of the CTJWG, with the aim of improving or enhancing the performance of clinical trials in Australia, and continue to deliver the Government’s priority of reducing the impact of regulation and red tape on business, community organisations and individuals.

Programmes Contributing to Outcome 7

Divisions Contributing to Outcome 7

In 2014-15, Outcome 7 was the responsibility of Acute Care Division, Best Practice Regulation and Deregulation Division, eHealth Division, National Industrial Chemicals Notification and Assessment Scheme, Office of the Gene Technology Regulator, Office of Health Protection, Pharmaceutical Benefits Division, Portfolio Strategies Division, Primary and Mental Health Care Division, and the Therapeutic Goods Administration.

Programme Performance

In 2014-15, the Department worked to achieve this Outcome by managing initiatives under the following programmes.


As at 30 June 2015, 9.5 per cent30 (2,277,010 people) of Australia’s population had registered for a PCEHR.

Figure 7.1: Percentage of State population with a PCEHR31

This horizontal bar graph shows the percentage of State population with a Personally Controlled Electronic Health Record (PCEHR) system. The ACT has the highest proportion of individuals with a PCEHR, constituting 17% of the state’s population.

Personally Controlled Electronic Health Record (PCEHR) System

The table below shows the progressive growth each year for the past three years of consumer registrations, healthcare provider organisation registrations, and eHealth document uploads. The data shown is as at the end of the 2012-13, 2013-14, and 2014-15 financial years.

Progressive Growth in Consumer Registrations
Progressive Growth in Healthcare Provider Organisations Registered
Total number of eHealth Clinical Documents stored in the PCEHR System at the end of each Financial Year
30 June 2013 397,742 4,324 3,767
30 June 2014 1,725,934 7,227 71,195
30 June 2015 2,277,010 7,773 226,458

Programme 7.1: eHealth

Programme 7.1 aims to provide national eHealth leadership and develop systems to provide eHealth services.

Operate a national eHealth system

In 2014-15, the Department continued to work with stakeholders on the recommendations of the review of the PCEHR to maximise the benefits of eHealth for the Australian community. A national consultation process was undertaken between July and September 2014 to obtain views from stakeholders on the implementation of the review recommendations. Feedback from these consultations informed the 2015-16 Budget announcement for the redevelopment and ongoing operation of the PCEHR, and informed the decision to undertake trials of new participation arrangements for individuals, including an opt-out system. The trials will inform future strategies for increasing uptake and meaningful use of the system to bring forward the benefits of the system for the Australian community.

Targeted education and training will be provided to GPs nationally, and other healthcare providers in trial sites. Training will range from online tools and tutorials, peer-to-peer training, face-to-face training and support in the workplace. From February 2016, the Practice Incentives Programme eHealth Incentive (ePIP) will be revised to require active and meaningful use of the system. The Department will continue to work with stakeholders to implement these changes.

The name of the system will change from the PCEHR to My Health Record.

Qualitative Deliverable: The Department, as the PCEHR system operator, applies good practice principles and methods for the operation and support of the PCEHR system.
2014-15 Reference Point: The PCEHR system operations and practices are regularly reviewed.
Result: Met
In applying and developing good practice principles and methods for the operation of the PCEHR system, the Department takes into consideration expert advice, feedback and recommendations from a range of stakeholders, including the Operations Management Committee, Jurisdictional Advisory Committee and the Independent Advisory Council.
Quantitative KPI: System availability
2014-15 Target: 99% of the time (excluding planned outages)
2014-15 Actual: 99.86% of the time
Result: Met
The Department worked with its partner organisations to improve PCEHR system availability. This work included improvements to system monitoring tools for early detection of technical issues, and implementation of infrastructure failover capability, to ensure system availability in the event of equipment failure.

Provide national eHealth leadership

In May 2015, the Minister for Health announced that the Government will establish the Australian Commission for eHealth. From 1 July 2016, the Commission will assume responsibility for both the existing national eHealth foundation infrastructure, managed by the National eHealth Transition Authority and the PCEHR managed by the Department. The Department will continue to work with the Australian community to implement changes to governance arrangements to ensure the Australian Commission for eHealth is representative of the users of the PCEHR.

In 2011, the Commonwealth and State and Territory Health Ministers commissioned a refresh of the National eHealth Strategy and Business Case, which guided national coordination and collaboration in eHealth. In 2014-15, work was paused pending the Government’s response to the review of the PCEHR, as the PCEHR is a core element of the Strategy. Work on finalising the Strategy and Business Case has recommenced in partnership with the States and Territories following the 2015 Budget announcement on redevelopment and ongoing operation of the PCEHR. It is planned to be tabled for Commonwealth and State and Territory Health Minister agreement in early 2016.

Qualitative Deliverable: Telehealth services are trialled in the home for aged care, palliative care and cancer care.
2014-15 Reference Point: The Department will evaluate the pilot programme on the use of telehealth services in the home.
Result: Met
The Telehealth Pilots Programme was extended until December 2014. An independent evaluation has been undertaken following completion of the programme and the report is currently being finalised.

Programme 7.2: Health Information

Programme 7.2 aims to provide support to the Australian Health Ministers’ Advisory Council and the Council of Australian Governments Health Council.

Provide support to the Council of Australian Governments (COAG) Health Council and Australian Health Ministers’ Advisory Council (AHMAC)

The Commonwealth, State and Territory Governments on the COAG Health Council work in partnership to improve health outcomes for all Australians and ensure the sustainability of the Australian health system. AHMAC provides support to the CHC by advising it on strategic issues relating to the coordination of health services across the nation and, as applicable, with New Zealand. AHMAC also operates as a national forum for planning, information sharing and innovation on health and hospital issues.

Qualitative Deliverable: Australian Government initiated activities undertaken by AHMAC and its Principal Committees support the COAG Health Council in providing leadership on national health issues.
2014-15 Reference Point: Relevant Australian Government priorities are highlighted and progressed in the activities of the Health Council.
Result: Met
During 2014-15, Australian Government priorities were progressed through AHMAC and CHC work programmes. This included work on issues such as: hospital and health services including primary care networks; coordination of care for people with chronic and complex conditions; Aboriginal and Torres Strait Islander health; eHealth; health workforce; mental health; safety and quality; and health promotion and prevention.
Quantitative KPI: Number of COAG Health Council meetings that address Australian Government priorities.
2014-15 Target: 2
2014-15 Actual: 2
Result: Met
In 2014-15, two COAG Health Council meetings were held with State and Territory Governments progressing Australian Government priorities.

Programme 7.3: International Policy Engagement

Programme 7.3 aims to facilitate international engagement on global health issues.

Facilitate international engagement on global health issues

The Department engages in multilateral and regional international health fora, and bilaterally with other countries and global health bodies, to help protect and advance the health of Australians. The Department’s efforts assist in fulfilling Australia’s responsibility, as an advanced economy, to help improve global and regional health outcomes.

The Department continued to support the work of the Department of Foreign Affairs and Trade to promote Australia’s broader international goals in global health policy and ensure Australian health interests are considered in free trade agreements.

Qualitative Deliverable: Australia’s interests secured at relevant meetings of key international health bodies and organisations.
2014-15 Reference Point: Departmental representatives will have actively engaged in meetings of the WHO governing bodies, OECD Health Committee, APEC Health Working Group and other international fora.
Result: Met
The Department continued to make a strong contribution to international health fora in 2014-15 supporting Australia’s continued leadership in global public health. The Department actively engaged in the OECD Health Committee and in a number of working groups and projects. Continued efforts to promote and protect Australia’s interests in addressing regional and global health policy priorities were made and the Department played a key role in advancing significant agendas relating to health security, strengthening health systems and non-communicable disease prevention and control.

In our region, the Department actively participated in the Western Pacific Regional Committee of WHO and executed the Asia Pacific Economic Cooperation (APEC) Health Working Group agenda by pursuing enhanced health security preparedness, supported by strengthened multi-sectoral capacity. The Department led Australia’s delegations to the Pacific Health Ministers Meeting and the Pacific Heads of Health Meeting, contributing to strategic policy objectives for Pacific health ministries, in particular in the area of non-communicable diseases.
Quantitative Deliverable: Number of international health delegations visits facilitated by the Department.
2014-15 Target: 20-25
2014-15 Actual: 20
Result: Met
Incoming visits from overseas delegations are an important means of engaging with other countries to build networks and professional linkages between individuals and organisations, and to share technical information and experiences in different aspects of health systems development. In 2014-15, the Department hosted visits from 20 overseas delegations interested in learning more about various parts of Australia’s health system.
Qualitative KPI: Australia’s health interests are advanced through participation in the WHO Executive Board.
2014-15 Reference Point: Departmental representatives will have made effective interventions on key agenda items at the WHO Executive Board.
Result: Met
The Department played a key role as a Member of the WHO Executive Board in 2014-15, brokering consensus on a range of significant decisions and resolutions, including on global health security and antimicrobial resistance. The Department made a valuable contribution to strengthening and improving WHO’s emergency response capacities during the Executive Board’s Special Session on the Ebola outbreak crisis in January 2015. Australia’s three year term on the Executive Board ended in 2015.

The Department also contributed to a number of activities under the WHO Executive Board including the Expert Committee on the Specifications for Pharmaceutical Preparations, the Expert Committee on Biological Standardization, and the working group on Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medicinal Products.

Programme 7.4: Research Capacity and Quality

Programme 7.4 aims to improve research capacity, and improve safety and quality in health care.

Improve research capacity

Medical Research Future Fund

As part of the 2014-15 Budget, the Government announced the $20 billion Medical Research Future Fund (MRFF). The MRFF will provide a sustainable source of funding for vital medical research and deliver a major additional injection of funds into the medical research sector, complementing research funding allocated by the National Health and Medical Research Council (NHMRC). The MRFF will drive innovation, improve delivery of health care, boost the efficiency and effectiveness of the health system, and contribute to economic growth.

The first distributions from the MRFF of $10 million will occur in 2015-16, with approximately $400 million to be distributed over the next four years. The development of a disbursement strategy for the MRFF commenced in 2014-15. The strategy will take into account a broad range of factors including the health conditions contributing to Australians’ burden of disease, the current profile of medical research investment in Australia, and where the opportunities are for making a real difference through targeted additional investment.

In 2014-15, the Department worked with relevant Government agencies to develop legislation establishing the MRFF. The Medical Research Future Fund Bill 2015 was introduced into Parliament on 27 May 2015, and amendments were introduced on 22 June 2015.

Clinical trials

Clinical trials are a critical element of translating research into better care. The Australian Government is leading a body of work to improve the clinical trials environment with a view to improve health outcomes and increase international investment in Australia.

The Department is working with the Department of Industry and Science, the NHMRC, State and Territory Governments and other stakeholders to reduce the time taken for clinical trial approvals and to progress improvements to the sector. This work is being pursued through the Clinical Trials Advisory Committee.

In 2014-15, the Clinical Trials Jurisdictional Working Group (CTJWG) was established to identify and address barriers to multijurisdictional clinical trials. The CTJWG produced an implementation plan that has been endorsed by Health Ministers, and includes a range of priority areas where efforts will be focused across all Australian jurisdictions. The CTJWG has already made considerable progress on these priorities.

The CTJWG will provide an important mechanism for coordinating and implementing activities across a range of priority areas including recruitment, ethics and governance, metrics, and positioning Australia as a good place to conduct clinical trials.

Qualitative Deliverable: Facilitate research translation into improved health care.
2014-15 Reference Point: Agreement reached by jurisdictions on addressing barriers to streamlined approval of clinical trials.
Result: Met
The CTJWG was formed in July 2014 with representation from all jurisdictions. The CTJWG has established joint cooperation and collaboration and has agreed on priorities to address barriers to streamlined approval of clinical trials in its implementation plan. Work is continuing on cooperative efforts to engender change and/or improvements in all priority areas.

Maintain effective health surveillance

Through the Health Surveillance Fund, the Department provided funds for data and information to inform the Blood Borne Viruses and Sexually Transmissible Infections Strategies, the National Drug Strategy, the National Human Papillomavirus Vaccination Program, the National Injury and Safety Promotion Plan, and to maintain the Social Health Atlas. Data and information were also obtained to monitor chronic vascular and respiratory conditions, antimicrobial resistance and usage, children’s health, the fatal burden of disease, and disease typing of a number of vaccine preventable diseases.

Qualitative Deliverable: Produce relevant and timely evidence-based disease surveillance data, information and research.
2014-15 Reference Point: Surveillance information available to inform national strategies.
Result: Substantially met
In 2014-15, all major reports were received. Three non-time critical communicable disease analysis summary reports have been deferred until early 2015-16 when more information will be available.

Monitor the use of diagnostics, therapeutics and pathology

The Department continued to support NPS MedicineWise, through the Quality Use of Diagnostics, Therapeutics and Pathology Fund, to provide information and support to consumers and health professionals on quality use of medicines and medical testing. This work results in improved health outcomes and contributes to the sustainability of the Pharmaceutical Benefits Scheme (PBS) and the Medicare Benefits Schedule.

During 2014-15, NPS MedicineWise continued its programme of health professional and consumer education activities focused on promoting safe use of medicines in older people, fatigue, inhaled medicines including asthma control, and high blood pressure. NPS MedicineWise undertook a range of work including educational visits, clinical audits and feedback to health professionals, to encourage the optimal use of pathology and diagnostic imaging referrals from general practice.

During the year, NPS MedicineWise inaugurated the Choosing Wisely Australia programme, based on an initiative of the American Board of Internal Medicine Foundation which commenced in 2012. The programme encourages health professionals to commence conversations with patients about commonly used medical tests, treatments and procedures that may be unnecessary and which may in some cases cause harm. As a collaboration of medical specialty and consumer organisations, Choosing Wisely Australia also recognises the role of health consumers in making informed choices about their own healthcare. A key intention of this programme is to encourage public dialogue on the use of medical interventions, and to pose the question ‘is a medical test the best option?’

NPS MedicineWise continued the development of MedicineInsight to improve post-market surveillance by capturing, storing and analysing de-identified clinical data from general practices to inform how medicines are being used in practice. In 2014-15, NPS MedicineWise reached its recruitment target of data collection from 500 general practices, a sufficient number to provide meaningful ‘real world’ data on medicines use which enables NPS MedicineWise to identify areas for improved prescribing and ultimately improving patient health outcomes. For further information on NPS MedicineWise, refer to the NPS website.32

Qualitative Deliverable: Information regarding quality use of medicines newly listed on the PBS is provided to health professionals where appropriate.
2014-15 Reference Point: The Department will produce information in a variety of formats throughout the year, including the Rational Assessment of Drugs and Research, the Australian Prescriber and an annual evaluation report.
Result: Met
The Department supported NPS MedicineWise to produce all scheduled publications, which provide evidence-based information on therapeutics, including new and revised listings of medicines on the PBS, for health professionals and consumers. Publications include the Rational Assessment of Drugs and Research (RADAR) and the Australian Prescriber, which is in its fortieth year of publication in 2015.
Quantitative KPI: Number of general practitioners participating in education initiatives.
2014-15 Target: 14,500
2014-15 Actual: 14,482
Result: Substantially met
In 2014-15, the NPS reported that 14,482 unique general practitioners participated in quality use of medicines education activities provided by the NPS. This compares to 13,129 in 2013-14 and 14,112 in 2012-13.

The National Return and Disposal of Unwanted Medicines (NatRUM) programme was established to reduce accidental poisoning of children, medication misuse and harmful effects on the environment by giving consumers the opportunity to return unwanted or expired medicines to any pharmacy for free, for destruction in an environmentally friendly manner.

The volume of unwanted medicines collected under the NatRUM programme has increased steadily since it commenced in 1998. In 2000-01 the collection totalled 235,267 kilos, while in 2014-15 this had grown to 654,880 kilos.

Improve safety and quality in health care

The Department, with the States and Territories, continues to work with the Australian Commission on Safety and Quality in Health Care (ACSQHC) to drive improvements in the Australian health system to ensure patients receive appropriate health care. The ACSQHC, in partnership with the Australian Institute of Health and Welfare and supported by the Department, led Australia’s participation in an OECD medical practice variation study, which examined nine procedures and interventions.

In 2014-15, the Department has continued work on a number of key activities including clinical management of blood,33 addressing antimicrobial resistance,34 and reducing unnecessary radiation exposure from diagnostic imaging. The Australian Atlas of Healthcare Variation is expected to be published in late 2015 and will inform future strategies to address unwarranted variation.

The Department funded the establishment of two clinical quality registries for high risk implantable cardiac and breast devices. The registries are expected to be fully operational in 2016 providing key information on device safety recalls, and longitudinal insight into patient outcomes.

Programme 7.5: Health Infrastructure

Programme 7.5 aims to improve and invest in major health infrastructure.

Improve primary health care infrastructure

In 2014-15, the Department conducted an Invitation to Apply process for the Rural and Regional Teaching Infrastructure Grants. Due to unforeseen delays, the Invitation to Apply process was deferred by more than four months. The assessment process has been finalised and successful applicants were notified in June 2015. $52.5 million has been provided over three financial years to enable regional and rural GP practices to build facilities to take on more trainees. The grants will support the provision of additional consultation rooms and space for teaching medical students and supervising GP registrars.

Quantitative KPI: Number of grants to support the provision of additional space for teaching and training to strengthen the rural workforce.
2014-15 Target: 100
2014-15 Actual: 10
Result: Not met
There were significant delays in going to market for this programme within the 2014-15 financial year. Funding agreements will be finalised in early 2015-16.

Invest in other major health infrastructure

In 2014-15, the Department continued to work with States and Territories and non-government organisations, universities, and medical research institutes to progress existing Health and Hospitals Fund (HHF) projects, including monitoring for compliance against key project milestones. The Department also continued its efforts to finalise agreements with all successful applicants under the HHF Regional Priority Rounds.

Qualitative Deliverable: Funding arrangements in place for all successful projects under the 2010 and 2011 Regional Priority Round of HHF grants.
2014-15 Reference Point: Remaining funding agreements signed by 31 December 2014.
Result: Substantially met
Under the 2010 and 2011 HHF Regional Priority Rounds, 139 successful projects were announced. Five of these projects have subsequently been cancelled at the funding recipients’ request. By December 2014, 93% of HHF Regional Priority Round projects had funding arrangements in place. The Department continues to work with Government and non-government organisations to finalise funding arrangements. As at 30 June 2015, five projects were yet to have funding arrangements in place. It is anticipated that these projects will be finalised before 31 December 2015.
Qualitative KPI: Effective monitoring of HHF projects for compliance with agreed outputs.
2014-15 Reference Point: Reports are received for all projects in the required timeframe and remedial action taken as required.
Result: Met
The majority of HHF funding recipients were compliant in providing project reports and achieving agreed project outputs within the required timeframes. Where projects were found to be non-compliant, the Department undertook remedial action in a timely manner.

Programme 7.6: Blood and Organ Donation

Programme 7.6 aims to improve Australians’ access to organ and tissue transplants, and support access to blood and blood products.

Improve Australians’ access to organ and tissue transplants

In 2014-15, the Department continued to support the Australian Organ and Tissue Donation and Transplantation Authority in implementing, coordinating and monitoring a national approach to organ and tissue donation for transplantation with the aim of increasing Australians’ access to life-saving and life-transforming transplants. The nationally coordinated approach is particularly targeted at donation processes and systems in hospital settings, and the awareness and education of professionals and the community. The Department also supported the Department of Human Services to administer the Supporting Leave for Living Organ Donors (SLLOD) Pilot, which commenced on 1 July 2013 and ended on 30 June 2015. The Department will take over the administration of the SLLOD Programme, which has been funded for a further two years from 1 July 2015.

Patients needing life-saving stem cell transplants are provided with the best opportunity to find a suitable stem cell match, with the Government continuing to support the Australian Bone Marrow Donor Registry (ABMDR), the Bone Marrow Transplant Programme and the National Cord Blood Collection Network (NCBCN).

The Clinical Services Plan for the NCBCN was reviewed in 2014-15, and updated by the Department to reflect changes in clinical practice and the Australian population’s composition. This will enable the NCBCN to manage and coordinate a national bone marrow register, undertake the identification of suitably matched, voluntary donors of haemopoietic progenitor cells (HPC), and collect, analyse and publish data relating to the outcomes of HPC donation and transplantation.

Qualitative Deliverable: Support the Australian Bone Marrow Donor Registry (ABMDR) and the National Cord Blood Collection Network to identify matched donors and stem cells for transplant.
2014-15 Reference Point: Increased diversity of tissue types of donors and cord blood units available for transplant.
Result: Met
The Department continues to support the ABMDR, which collects cord blood units at 11 collection centres across Australia, with a combined catchment broadly reflecting the genetic diversity of the Australian population. Processes for donor recruitment and education through cord blood collection and blood donor centres are being extended to further diversify the pool of donors and cord blood units for use by Australian patients.
Quantitative Deliverable: Number of banked cord blood units.
2014-15 Target:
  • Total: 2,379
  • Indigenous: 129
2014-15 Actual:
  • Total: 1,765
  • Indigenous: 119
Result: Substantially met
The number of cord blood units banked was lower than the target in 2014-15. However, this reflects the NCBCN shifting focus from the quantity of units collected to collecting cord blood units that are of a higher quality, and from families where one or more parent comes from an ethnically diverse background. Improving the ethnic diversity of the cord blood unit collection in Australia will provide a higher probability of a clinically useful match between donor and patient being found. Accordingly, 66% of banked cord blood units were from ethnically diverse donors in 2014-15, an increase of 16% from 2013-14. The number of banked Indigenous cord blood units increased by 18% in 2014-15, compared with 2013-14.
Quantitative KPI: Percentage of legitimate Bone Marrow Transplant Programme applications assessed and approved within four days of receipt.
2014-15 Target: 100%
2014-15 Actual: 100%
Result: Met
The Bone Marrow Transplant Programme continues to grow as needs increase.

Support access to blood and blood products

The Department ensured access to affordable and quality blood supply by delivering the Commonwealth’s contribution of funding to the blood sector and a Commonwealth contribution to national blood supply policy. The Department chaired the Jurisdictional Blood Committee (JBC) and continued to contribute to the development of strategies to support appropriate blood and blood product use, reduction in wastage, and a more efficient supply chain.

The Department worked with the National Blood Authority (NBA) and the ACSQHC to establish a National Patient Blood Management Collaborative, comprising 18 public and private hospitals focused on improving anaemia management for patients undergoing elective abdominal, gynaecological or orthopaedic surgery.

The Department continued to work with the NBA and State and Territory Governments to improve governance arrangements for prescribing and authorising evidence-based use of funded immunoglobulins. Following the JBC’s endorsement of the National Blood and Blood Product Waste Reduction Strategy 2013-17, the rate of red blood cells discarded (not able to be transfused before their date of expiry) has decreased from 5.0 per cent in 2013-14 to 4.2 per cent in the 10 months to April 2015.

The Department also contributed to the Hepatitis C Litigation Settlement Scheme, which provides a contribution to the out-of-court settlement costs for eligible people who contracted hepatitis C as a result of a blood transfusion in Australia between 1985 and 1991.

Qualitative Deliverable: Effective planning of the annual blood supply through the National Supply Plan and Budget.
2014-15 Reference Point: Implementation of the 2014-15 National Supply Plan and Budget agreed by all Health Ministers in 2013-14.
Result: Met
On 11 April 2014, Health Ministers agreed to the 2014-15 National Supply Plan and Budget. The Commonwealth’s contribution in 2014-15, based on the national cost-sharing arrangements, was expected to be up to $718 million. This funding ensured Australians have access to blood and blood products required for treatment of numerous medical conditions. These include cancer, heart, stomach, bowel, liver and kidney diseases, during and after surgery, treatment of traumatic injury or burns, and for treatment of chronic conditions including bleeding disorders (e.g. haemophilia) and immunodeficiency conditions.

Programme 7.7: Regulatory Policy

Programme 7.7 aims to maintain and improve the therapeutic goods and industrial chemicals regulatory frameworks, as well as provide direction and national leadership in gene technology regulatory policy issues.

Therapeutic Goods

Ensure that therapeutic goods are safe, effective and of high quality

The Therapeutic Goods Administration (TGA) is Australia’s regulator responsible for ensuring the safety, efficacy and quality of therapeutic goods in Australia. In 2014-15, consistent with the Australian Government’s deregulation and red tape reduction agenda, the TGA has continued work to identify areas for improvement to regulation.

In October 2014, the Government announced the Expert Review of Medicines and Medical Devices Regulation (the Review). Chaired by Professor Lloyd Sansom AO, the aim of the Review was to identify unnecessary regulation that could be removed without reducing the safety or quality of therapeutic goods. The Review also looked to identify opportunities to enhance the regulatory framework, to better respond to global trends in the development, manufacture, marketing and regulation of therapeutic goods.

The Review’s first report, which looked at the regulatory framework for medicines and medical devices, was published on 24 June 2015. The 32 recommendations of the first report are currently under consideration by the Government. A second report that will look at the regulatory framework for complementary medicines and the advertising of therapeutic goods, is due to be delivered to the Government in mid 2015.

In 2014-15, the TGA also worked closely with industry on new initiatives to help improve the efficiency of a number of application and administrative processes. This included implementing a new business services portal to provide industry with self-service technology to conduct simple regulatory transactions with the TGA.

For medicines, the pilot to introduce the electronic Common Technical Document (eCTD) format for over-the-counter and prescription medicines, was completed, eliminating the need for paper applications. Other initiatives included releasing an electronic smart form for sponsors to notify the TGA of prescription medicines shortages, reducing the reliance on phone, email and letter communication.

Medical devices initiatives included implementation of regulatory changes to allow Australian medical devices manufactures to obtain market approval for most products using European notified bodies’ conformity assessment.

Qualitative Deliverable: Contribute to the Government’s deregulation and red tape reduction agenda by identifying and progressing opportunities to reduce red tape.
2014-15 Reference Point: Complete a review to identify opportunities to reduce regulatory burden and red tape.
Result: Substantially met
During the reporting period an independent review was conducted to examine specific aspects of the regulatory framework for medicines and medical devices. Pending the outcomes of the review, the TGA conducted a number of activities that contributed to the Government’s deregulation and red tape reduction agenda.
Quantitative KPI: Percentage of evaluations/assessments completed within legislated timeframes:
  1. Applications lodged under prescription medicines registration (Category 1 applications) processed within 255 working days
  2. Quality related evaluations of prescription medicines (Category 3 applications)processed within 45 working days
  3. Conformity assessments for medical devices processed within 255 working days.
2014-15 Target: a. 100%
b. 100%
c. 100%
2014-15 Actual: a. 99.7%
b. 98%
c. 100%
Result: a. Substantially met
b. Substantially met
c. Met
In 2014-15:
  • 344 of 345 Category 1 evaluations for prescription medicines were completed within the legislated timeframe of 255 days.
  • 1,442 of 1,465 Category 3 evaluations for prescription medicines were completed within the legislated timeframe of 45 days.
  • 151 of 151 conformity assessments for medical devices were processed within the legislated timeframe of 255 days.
Category 199.5%99.7%99.8%
Category 399.4%100%100%
Quantitative KPI: Percentage of alleged breaches of the Therapeutic Goods Act 1989 received that are assessed within 10 working days and an appropriate response initiated.
2014-15 Target: 100%
2014-15 Actual: 100%
Result: Met
The TGA assessed 1,259 alleged breaches of the Therapeutic Goods Act 1989 within 10 working days and initiated appropriate responses in 100% of the instances notified.
Quantitative KPI: Percentage of licensing and surveillance inspections completed within target timeframes:
2014-15 Target:
  • Domestic: 100%
  • Overseas: 90%
2014-15 Actual:
  • Domestic: 72%
  • Overseas: 79%
Result: Substantially met
The TGA continued to direct efforts to raising levels of compliance by manufacturers particularly those producing high risk products.

International regulatory harmonisation and work sharing

During 2014-15, the TGA has developed and strengthened collaborative arrangements with international regulatory agencies through engagement in international therapeutic goods fora, participation in information sharing programmes, and maintaining a key role in the international harmonisation of standards for medicines.

In November 2014, the TGA laboratories were recognised internationally by being redesignated for another four years as a WHO collaborating centre for drug quality assurance.

Qualitative Deliverable: Implement international harmonisation, work sharing and joint operations with comparable international regulators.
2014-15 Reference Point: Enhanced cooperation and work sharing including increased reliance on information from international regulators.
Result: Met
Collaborative activities with international regulatory agencies in 2014-15 included membership of the Executive Committee of the International Coalition of Medicines Regulatory Authorities; agreements to conduct joint inspections of overseas medicines manufacturers; engagement in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme to progress the international harmonisation of standards; progressing the development of international protocols for sharing confidential information with trusted regulators; training with countries developing regulatory systems in the Asia Pacific region; and participation in the International Generic Drug Regulators Programme through which assessment reports can be shared in real time with collaborating regulatory agencies outside the European Union.

Continue therapeutic goods reform process

In 2014-15, the TGA developed a range of tools to improve communication about the role of the TGA to the Australian public, and to assist industry with meeting regulatory requirements. Progress was made on harmonisation, deregulation, streamlined market approvals and reducing costs to business. This is consistent with the Government’s focus on deregulation and reducing the cost of red tape for business, community organisations and individuals. Outcomes of the Expert Review of Medicines and Medical Devices Regulation, will also contribute to the reform process.

Qualitative Deliverable: Implement reforms that enhance TGA’s current regulatory processes.
2014-15 Reference Point: Reforms implemented in accordance with the published plan for TGA Reforms: A blueprint for TGA’s future.
Result: Substantially met
Of the 48 Blueprint recommendations proposed for implementation by the TGA, 38 recommendations had been implemented by 30 June 2015. During 2014-15, the TGA developed and published agreed key performance indicators to provide quantitative and qualitative information on the TGA’s organisational effectiveness and operational efficiency, and made significant enhancements to the TGA website to be more user-friendly for industry, health professionals and consumers.35

Progress of five Blueprint reforms planned for this period has been put on hold pending the outcome of the Expert Review of Medicines and Medical Devices Regulation (the Review) and the Government’s response to the Review’s recommendations. This includes areas where the Review intersects with planned reforms in the areas of complementary medicines, advertising and medical devices, which will be considered in the future under the agreed outcomes.
Quantitative Deliverable: Number of reforms implemented to enhance TGA’s regulatory processes.
2014-15 Target: 2
2014-15 Actual: 1
Result: Substantially met
The revision of the Uniform Recall Procedures for Therapeutic Goods (URPTG) (TRR 16) has progressed, however has not been completed as forecast. Following consultation, the stakeholder submissions will inform the redrafting of the URPTG and in 2015-16 the TGA expects to finalise the revised version following an open consultation on the draft document.

Industrial Chemicals

Aid in the protection of the Australian people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use

In 2014-15, through the administration of NICNAS, the Department continued to promote the safe use of industrial chemicals to protect human health and the environment.

In August 2014, the functions of the Department relating to chemical regulation were realigned and consolidated within the Office of Chemical Safety, bringing together staff working on the assessment of industrial chemicals, agricultural and veterinary chemicals, and the scheduling of chemical poisons.

A report on the operation of the Industrial Chemicals (Notification and Assessment) Act 1989 is available as an appendix to this report.

Qualitative Deliverable: Scientifically robust assessments of new and existing industrial chemicals.
2014-15 Reference Point: Peer review and stakeholder feedback support assessment outcomes.
Result: Met
In 2014-15, NICNAS published assessment reports for 213 new chemicals, two Priority Existing Chemicals, and published two reports following secondary notification of previously assessed chemicals. No reviews of NICNAS’s chemical assessments were conducted by the Administrative Appeals Tribunal.
Qualitative Deliverable: High quality assessment outcomes are produced through effective use of the Inventory Multi-tiered Assessment and Prioritisation (IMAP) framework.
2014-15 Reference Point: Stakeholder engagement and communication strategies continue to be effectively implemented to contribute to the quality and uptake of assessment outcomes.
Result: Met
NICNAS made 1,241 recommendations to manage newly identified risks associated with the industrial use of 992 unique chemicals assessed under the IMAP framework. In all cases, interested parties were given the opportunity to comment on those recommendations. NICNAS staff engaged with stakeholders, and met with key Australian risk management agencies to promote the uptake of recommendations.
Qualitative Deliverable: Contribution to the international harmonisation of regulatory approaches and methodologies for assessing industrial chemicals by reviewing Australian processes.
2014-15 Reference Point: Review international regulatory approaches and methodologies from three key sub-committees of the OECD Chemicals Committee for their application to NICNAS assessments of industrial chemicals.
Result: Met
In 2014-15, NICNAS was represented in the Australian delegation to the OECD Chemicals Committee and its key subsidiary committees: the Task Force on Hazard Assessment; Clearing House on New Chemicals; Working Party on Manufactured Nanomaterials; and the Task Force on Exposure Assessment. NICNAS contributed to a review of the applicability of OECD guidelines to testing manufactured nanomaterials as well as to the status of alternatives to animal testing methods, the mutual acceptance of new chemicals notifications and the development of integrated approaches to testing and assessment of chemicals. Participation in these groups facilitates greater international harmonisation of NICNAS assessment methodologies.
Qualitative Deliverable: All introducers of industrial chemicals are aware of their legal obligations.
2014-15 Reference Point: Register identified introducers and provide regular information updates.
Result: Met
At the end of 2014-15, 99.9% of identified introducers were registered with NICNAS. The total number of 5,794 introducers registered for 2014-15 represented the highest total number of registrants since the introduction of NICNAS registration. A total of eight information sessions were delivered to over 420 attendees in major capital cities and regional areas.
Qualitative Deliverable: The costs associated with the regulation of industrial chemicals are adequately balanced against the benefits to worker health and safety, public health and the environment.
2014-15 Reference Point: Reforms to NICNAS more efficiently and effectively achieve the objects of the Industrial Chemicals (Notification and Assessment) Act 1989.
Result: Met
As part of the 2015 Federal Budget, the Australian Government announced the implementation of reforms to notification and assessment of industrial chemicals. The reforms, which focus regulatory effort on higher risk chemicals and continue the protection of human health and the environment, deliver a reduction of approximately $23 million per annum in the burden of regulation on industry.
Qualitative KPI: Effective use of international information.
2014-15 Reference Point: International hazard assessment information incorporated into assessments.
Guidance and training on the use of international information provided to assessors.
Result: Met
NICNAS regulatory scientists continued to use information on the hazards of industrial chemicals obtained from a range of international sources in conducting assessments of the risks of the use of these chemicals in Australia. NICNAS scientists engaged with their counterparts in comparable international regulatory agencies and global industry associations to obtain and review relevant information, and received ongoing professional development in a range of assessment-focused areas. In addition, NICNAS internal databases were updated with new internationally validated testing guidelines and assessment methods to enable assessors to effectively interpret the latest information. Twelve assessments from comparable international agencies were incorporated in NICNAS new chemicals assessments.
Quantitative KPI: Percentage of new chemical assessments completed within legislated timeframes.
2014-15 Target: 96%
2014-15 Actual: 98%
Result: Met
NICNAS completed 334 certificate and permit assessments for new industrial chemicals, with 327 of these completed within legislated timeframes.
Quantitative KPI: Cumulative percentage of Stage One chemicals assessed through effective application of IMAP framework.
2014-15 Target: 90%
2014-15 Actual: 93%36
Result: Met
Using the IMAP Framework, NICNAS completed 1,802 assessments in 2014-15 for chemicals that may already be in use in Australia. These included 454 Tier I (high throughput) and 1,348 Tier II (chemical by chemical) assessments.
Quantitative KPI: Percentage of NICNAS registrants introducing over $500,000 of industrial chemicals assessed for compliance with new chemicals obligations.
2014-15 Target: 40%
2014-15 Actual: 40%
Result: Met
During 2014-15, 40% of registrants that had introduced relevant industrial chemicals with a value above $500,000 were screened for evidence of compliance with new chemicals obligations. This resulted in 55 organisations being selected for further risk assessment. Twenty-seven of these registrants were required to provide NICNAS with evidence of compliance with the new chemicals obligations. The 2014-15 audit identified eight companies potentially in breach of their new chemicals obligations. NICNAS continues to work with these companies, and those that are yet to provide the requested information, to achieve compliance with relevant legislation.

Gene Technology Regulation

Protect the health and safety of people and the environment by regulating work with genetically modified organisms (GMOs)

The Gene Technology Regulator, supported by the Office of the Gene Technology Regulator (OGTR), administers the national gene technology regulatory scheme, comprising the Gene Technology Act 2000 and corresponding State and Territory legislation, to protect the health and safety of people and the environment by regulating certain activities with genetically modified organisms (GMOs).

In 2014-15, the Department, including the OGTR, progressed the technical recommendations from the review of the Gene Technology Act 2000 to improve operational flexibility and reduce regulatory burden. The Gene Technology Amendment Bill 2015, which implements the legislative amendments from the review, was introduced into Parliament in June 2015. During the period, the OGTR reviewed guidelines and processes to enhance the efficiency and effectiveness of the gene technology regulatory system, including consulting on the development of a new application form for commercial releases of genetically modified (GM) plants.

In 2014-15, the OGTR ensured that all risk assessments of GMO licence applications were based on current scientific evidence and international best practice informed by consultation with experts and key stakeholders. To keep pace with advances in scientific knowledge and regulatory practice, the OGTR engaged in a number of international fora, including the OECD, to promote harmonisation of risk assessment of GMOs.

Throughout 2014-15, in order to maintain openness and transparency of the decision making processes, the OGTR fulfilled statutory requirements for public consultation on release of GMOs into the environment. A comprehensive record of approved GMO dealings, and further information about GMO regulation, is available on the OGTR website.37

The OGTR also continued to monitor certified containment facilities and the conduct of work with GMOs to ensure compliance with licence conditions. The gene technology legislation requires that certain dealings or activities (for example, experiments and field trials) with GMOs must be licensed before they can be conducted. The purpose of licensing is to protect human health and the environment by identifying and managing risks posed by GMOs. The OGTR prepares risk assessment and risk management plans for all licence applications, which form the basis of the Regulator’s decisions on whether or not to issue licences and/or conditions of each licence.

During 2014-15, bilateral arrangements with other Australian Government regulators continued to enhance reciprocal provision of advice on applications to support timely, efficient and comprehensive assessment of GMOs and genetically modified products. The OGTR commenced a joint initiative with the Department of Agriculture aimed at harmonising regulatory requirements for containment facilities.

Qualitative Deliverable: Progress improvements to OGTR operations recommended by all Australian Governments’ response to the Review of the Gene Technology Act 2000.
2014-15 Reference Point: Implementation completed within agreed timeframes.
Progress of agreed minor and technical amendments to increase flexibility and reduce regulatory burden.
Result: Met
In 2014-15, the OGTR undertook a range of activities to improve communication and consultation with regulated stakeholders and the public. In particular, the OGTR undertook a significant revamp of its website informed by feedback from stakeholders, and continued to use social media tools to disseminate information. The Department progressed minor and technical amendments on the Gene Technology Amendment Bill 2015 that was introduced into Parliament in June 2015.
Qualitative Deliverable: Provide effective regulation of GMOs that is open and transparent.
2014-15 Reference Point: Risk assessments and risk management plans prepared for all applications for licenced dealings.
Stakeholders, including the public, consulted on all assessments for proposed release of GMOs into the environment.
Record of GMO dealings and maps of all field trial sites maintained and made publicly available on the OGTR website.
Result: Met
In 2014-15, the Regulator prepared comprehensive risk assessments and risk management plans and consulted with stakeholders on nine GMO licence applications for intentional release into the environment (six field trials, one clinical trial, a commercial GM canola and a commercial GM vaccine for poultry). The Regulator also prepared risk assessments and risk management plans for ten licence applications for work in contained facilities. The OGTR maintained a record of approved GMOs and maps of all field trial sites, and made them available on the OGTR website.
Quantitative Deliverable: Percentage of field trial sites and higher level containment facilities inspected.
2014-15 Target: ≥20%
2014-15 Actual: 44% (field trial sites) and 29% (higher level containment facilities)
Result: Met
In 2014-15, the OGTR inspected 44% of field trial sites to monitor compliance with licence conditions ensuring risks to human health and the environment are minimised. Sites were inspected in the Northern Territory, New South Wales, Victoria, Queensland and Western Australia. Inspections included GM canola, wheat, barley, cotton, sugarcane, banana and safflower.

The OGTR also inspected 29% of higher level containment facilities to ensure compliance with certification conditions. These inspections focused on the integrity of the physical structure of the facility and on the general laboratory practices followed.
Qualitative KPI: Protect people and environment through identification and management of risks from GMOs.
2014-15 Reference Point: Comprehensive and effective risk assessment and risk management of GMOs.
High level of compliance with the gene technology legislation and no adverse effect on human health or environment from authorised GMOs.
Result: Met
Routine monitoring of the regulated community found a high level of compliance with the gene technology legislation.
Qualitative KPI: Facilitate cooperation and provision of advice between relevant regulatory agencies with responsibilities for GMOs and/or genetically modified products.
2014-15 Reference Point: High degree of cooperation with relevant regulatory agencies and provision of timely advice.
Result: Met
In 2014-15, the OGTR continued cooperative arrangements with other Australian Government regulators to enhance coordinated decision making and avoid duplication in regulation of GMOs and genetically modified products.

The OGTR engaged in international fora relevant to the GMO regulation including the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology and the 13th International Symposium on the Biosafety of GMOs. Regulators from other countries continued to seek input from the OGTR because the Australian scheme is considered a model for robust, practical and efficient regulation of GMOs. The OGTR also provided technical support to Australian engagement for the 2014 meetings of the UN Convention on Biological Diversity and Cartagena Protocol on Biosafety.
Quantitative KPI: Percentage of license decisions made within statutory timeframes.
2014-15 Target: 100%
2014-15 Actual: 95%
Result: Substantially met
The Regulator made decisions on all licence applications except for one within the applicable statutory timeframes. The decision on one application was made 19 days after the statutory timeframe due to an unavoidable delay in mandatory gazettal for consultation. There were no appeals of decisions made under the gene technology legislation.

Outcome 7 – Financial Resource Summary

(B) - (A)
Programme 7.1: eHealth1
Administered expenses
Ordinary annual services (Appropriation Act No. 1)135,221114,439(20,782)
Non cash expenses218,30918,309-
Departmental expenses
Departmental appropriation322,18920,166(2,023)
Expenses not requiring appropriation in the current year49381,209271
Total for Programme 7.1176,657154,123(22,534)
Programme 7.2: Health Information
Administered expenses
Ordinary annual services (Appropriation Act No. 1)27,91427,551(363)
Departmental expenses
Departmental appropriation31,5771,472(105)
Expenses not requiring appropriation in the current year4769822
Total for Programme 7.229,56729,121(446)
Programme 7.3: International Policy Engagement
Administered expenses
Ordinary annual services (Appropriation Act No. 1)14,91214,909(3)
Departmental expenses
Departmental appropriation312131
Expenses not requiring appropriation in the current year411-
Total for Programme 7.314,92514,923(2)
Programme 7.4: Research Capacity and Quality1
Administered expenses
Ordinary annual services (Appropriation Act No. 1)82,15281,304(848)
Departmental expenses
Departmental appropriation315,99616,193197
Expenses not requiring appropriation in the current year47231,015292
Total for Programme 7.498,87198,512(359)
Programme 7.5: Health Infrastructure1
Administered expenses
Ordinary annual services (Appropriation Act No. 1)62,07642,236(19,840)
Special accounts
Health and Hospitals Fund Health Portfolio Special Account719,802719,416(386)
Departmental expenses
Departmental appropriation39,1929,22028
Expenses not requiring appropriation in the current year4435603168
Total for Programme 7.5791,505771,475(20,030)
Programme 7.6: Blood and Organ Donation1
Administered expenses
Ordinary annual services (Appropriation Act No. 1)18,05816,736(1,322)
Special appropriations
National Health Act 1953 - blood fractionation, products and blood related products - to National Blood Authority535,345535,745400
Departmental expenses
Departmental appropriation34,9824,939(43)
Expenses not requiring appropriation in the current year423231583
Total for Programme 7.6558,617557,735(882)
Programme 7.7: Regulatory Policy
Administered expenses
Ordinary annual services (Appropriation Act No. 1)10595(10)
Departmental expenses
Departmental appropriation331,50928,169(3,340)
to Special accounts(17,484)(16,743)741
Expenses not requiring appropriation in the current year4612729117
Special accounts
OGTR Special Account57,9817,387(594)
NICNAS Special Account613,26714,3531,086
TGA Special Account7149,392137,499(11,893)
Expense adjustment8(8,521)(3,271)5,250
Expenses not requiring appropriation in the current year4-1212
Total for Programme 7.7176,861168,230(8,631)
Outcome 7 Totals by appropriation type
Administered expenses
Ordinary annual services (Appropriation Act No. 1)340,438297,270(43,168)
Non cash expenses218,30918,309-
Special accounts719,802719,416(386)
Special appropriations535,345535,745400
Departmental expenses
Departmental appropriation385,45780,172(5,285)
to Special accounts(17,484)(16,743)741
Expenses not requiring appropriation in the current year43,0173,970953
Special accounts162,119155,980(6,139)
Total expenses for Outcome 71,847,0031,794,119(52,884)
Average staffing level (number) 1,134 1,130(4)
  1. This Programme includes National Partnerships payments to State and Territory Governments by the Treasury as part of the Federal Financial Relations Framework.
  2. ‘Non cash expenses’ relates to the depreciation of computer software.
  3. Departmental appropriation combines ‘Ordinary annual services (Appropriation Act No. 1)’ and ‘Revenue from independent sources (s74)’.
  4. ‘Expenses not requiring appropriation in the budget year’ is made up of depreciation expense, amortisation, make good expense and audit fees.
  5. Office of the Gene Technology Regulator Special Account.
  6. National Industrial Chemicals Notification and Assessment Scheme Special Account.
  7. Therapeutic Goods Administration Special Account.
  8. Special Accounts are reported on a cash basis. The adjustment reflects the difference between cash and expenses.

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