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Outcome 5 - Regulation, Safety and Protection

Regulation, Safety and Protection

Protection of the health and safety of the Australian community and preparedness to respond to national health emergencies and risks, including through immunisation initiatives, and regulation of therapeutic goods, chemicals, gene technology, and blood and organ products

Highlights

 Immunisation rates continue to increase. Five year old immunisation coverage rates are at 94.9 per cent and are expected to continue to rise. Program 5.3.
 The influenza vaccine is provided at no cost for pregnant women, under the National Immunisation Program. Over 2,000 industrial chemicals were assessed for health and environmental risks. 17 new licences were issued for work with GMOs. 70% of scientific research licences for GMOs are for medical research and 30% are for agricultural research.

Programs contributing to Outcome 5

Summary of results against

performance criteria

Program

Targets met

Targets substantially met

Targets not met

Program 5.1: Protect the Health and Safety of the Community Through Regulation

9

-

-

Program 5.2: Health Protection and Emergency Response

4

-

-

Program 5.3: Immunisation

1

1

-

Total

14

1

-

Program 5.1: Protect the Health and Safety of the Community Through Regulation

The Department met all performance targets related to this program.

The Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC), the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), the Office of Chemical
Safety (OCS) and the Office of the Gene Technology Regulator (OGTR) are committed to protecting the health and safety of the community through their respective regulation areas and practices.

During 2018-19, the TGA increased stakeholder engagement in its domestic and international activities, particularly in relation to compliance under the Therapeutic Goods Act 1989. The TGA continues to improve access pathways to therapeutic goods and is increasing use of assessments of medicines and medical devices by comparable overseas regulators. The ODC regulates the importation, exportation and manufacture of narcotic drugs and the cultivation, production and manufacture of medicinal cannabis. The ODC is continuing to improve assessment processes and investigations for the associated risks.

The OCS continued to administer NICNAS, while also preparing to implement the new Australian Industrial Chemicals Introduction Scheme (AICIS) on 1 July 2020. The new scheme makes regulatory effort more proportionate to the risks posed by industrial chemicals and promotes safer innovation by encouraging the introduction of lower risk chemicals. Regulatory changes commenced in April 2019, reducing the regulatory red tape burden on industry under NICNAS ahead of more extensive reforms under AICIS.

The Gene Technology Regulatory Scheme administered by the OGTR continued to ensure matters regarding genetically modified organisms (GMOs) were approached in accordance with practices that best protect community health and safety and the environment.

The ban on cosmetic testing on animals continues to improve through the strengthening of existing frameworks and the amendment to the Australian code for the care and use of animals for scientific purposes.

The community can be confident that therapeutic goods approved for use in Australia have been assessed against strict standards.

Regulating therapeutic goods for safety, efficacy, performance and quality while promoting best practice

Intelligence, monitoring and compliance functions are improved to ensure compliance with the Therapeutic Goods Act 1989.

Source: 2018-19 Health Portfolio Budget Statements, p.122

2018-19 Target

2018-19 Result

Review the Compliance and Enforcement Plan, ensuring it is updated to reflect any legislative amendments in relation to sanctions and penalties.

Through effective inter-agency partnerships and enhanced relationships with state and territory counterparts, monitor and use intelligence to target non-compliance.

Remove illegal and/or non-compliant therapeutic goods that pose an unacceptable risk from the Australian market.

Through the 2018-19 Compliance and Enforcement Plan, the Department continued to strengthen inter-agency partnerships, greatly enhancing relationships with state and territory counterparts and continued to strengthen the Department’s working relationship with the Australian Border Force.

A total of 1,069,946 units of unapproved therapeutic goods were destroyed in the 2018-19 period.

Result: Met

Stakeholder engagement was enhanced both domestically and internationally, including through the execution of joint compliance activities across state, territory, Federal and international jurisdictions.

All allegations of compliance breaches were assessed against the Case Categorisation and Prioritisation Model to determine the appropriate compliance action to be applied.

The Health Products Regulation Group protects the community through monitoring the safety, efficacy, performance and quality of therapeutic goods available within Australia and removing non-compliant therapeutic goods from the market.

Access to therapeutic goods for consumers is improved whilst the safety of therapeutic goods in Australia is maintained.

Source: 2018-19 Health Portfolio Budget Statements, p.122 and Health Corporate Plan 2018-19, p.6

2018-19 Target

2018-19 Result

Continue implementation of the Australian Government’s reforms arising from the Review of Medicines and Medical Devices Regulation, which will improve access to safe therapeutic goods for Australian consumers.

Implementation was progressed through:

  • embedding new regulatory pathways for market authorisation of prescription medicines and increasing use of overseas assessments;
  • strengthening monitoring and compliance provisions; and
  • more effective regulation of therapeutic goods advertising.

Result: Met

Key reforms included:

  • establishing new regulatory pathways allowing priority review of medical devices;
  • enabling some overseas assessments of medical devices to be used to support shorter assessment times; and
  • establishing a new pathway where listed complementary medicines can be assessed for effectiveness.

Early access to medicines was improved for Australian patients through the introduction of new regulatory pathways that fast track market authorisation of prescription medicines where specific eligibility is met. A significant number of sponsors utilised these pathways in this period resulting in 14 priority determinations and five priority approvals, as well as two provisional determinations in this time period.

A new provisional approval pathway was introduced, which will enable provisional registration of prescription medicines on the basis of preliminary clinical data where there is a potential for substantial benefits to Australian patients. This could result in access to medicines years earlier.

The registration process for prescription medicines supplies in Australia has also been streamlined. This was done by the use of comparable overseas regulator evaluation reports. Utilising these reports reduces duplication of evaluation work, while maintaining existing quality, safety and efficacy standards for prescription medicines supplied in Australia.

The reform to orphan drug designation criteria has led to better targeted provision of fee-free evaluations for sponsors and access to medicines for patients with rare conditions. The community can view determinations for priority review and provisional approval on the TGA website.1

Legislative amendments to support the implementation of some recommendations will be of particular interest to patients, consumer groups, health care professionals and industry.

These reforms will:

  • increase transparency for both consumers and industry;
  • increase consumer knowledge on the products they are purchasing; and
  • improve compliance rate and consumer safety.

Positive feedback was received on all new pathways. Indicative of this feedback was the number of determinations/ designations (which are publicly available on the TGA website), as well as feedback provided at various conferences, poster presentations and other educational events. The completion of evaluations and assessments within legislated timeframes provided access to new or varied prescription medicines and medical devices, blood, cell and tissue therapies. This contributed to better health outcomes and reduced inequality for Australians.

Case Study
New Active Substance Work-Sharing Initiative

The New Active Substance Work-Sharing Initiative is an international collaboration that brings together the therapeutic goods regulatory authorities of Australia, Canada, Switzerland and Singapore (ACSS Consortium) to review new medicine applications.

The ACSS Consortium is one of a number of international initiatives in which the Therapeutic Goods Administration (TGA) engages to meet the needs of the Australian people and provide improved access to the most recent and innovative medicines.

The TGA’s engagement with ACSS Consortium partners maximises the use of up-to-date technical expertise, and ensures a consistent, contemporary approach to assessing the benefits and risks associated with new medicines. This unique international collaboration reduces regulatory duplication, creates efficiencies, and results in better access to safe medicines in the community.

In 2018-19, this partnership resulted in three new medicines – Apalutamide (Erlyand), Abemaciclib (Verzenio), and most recently Niraparib (Zejula) – receiving market approval in Australia and Canada. These medicines can provide alternative treatment options for some prostate, breast and ovarian cancers for both Australian and Canadian patients.

Engaging in these partnerships means new medicines can be made accessible to the Australian community quicker, and contributes to improved health and safety outcomes.

This international work-sharing initiative facilitates cooperation and collaboration across multiple regulatory authorities, reduces duplication of effort and increases each agency’s capacity to ensure consumers have timely access to high quality, safe and effective medicines.

This image depicts the Australia-Canada-Singapore-Switzerland (ACSS) Consortium logo.

The quality and safety of medicines and medical devices in Australia is supported by contributing to the evolving international environment.2

Source: 2018-19 Health Portfolio Budget Statements, p.123

2018-19 Target

2018-19 Result

Increase engagement with overseas regulators in comparable health systems, and with regional and international organisations, to improve public health and safety.

Increase use of overseas assessments by comparable regulators, while maintaining sovereignty of regulatory decisions.

The Department increased engagement with overseas regulators, including working with countries in the Asia-Pacific to increase public health and safety in the region.

The Department hosted delegations from international regulators and engaged with regional and international health organisations, including the World Health Organization. The Department also worked with the Australia-Canada-Singapore-Switzerland (ACSS) Consortium. These interactions ensure ongoing collaboration and knowledge with overseas regulators to improve public health and safety with respect to the regulation of therapeutic goods.

There has been an increase in the use of assessments by comparable overseas regulators as well as international work sharing, particularly with respect to prescription medicines for faster approvals and patient availability, while maintaining sovereignty of regulatory decisions. Additionally, joint inspections with comparable overseas regulators and use of their inspection reports for desktop assessments, continued to be undertaken to increase engagement and information sharing.

Result: Met

The Department continued to participate in international fora that promoted information sharing, cooperation and regulatory convergence in relation to therapeutic goods as outlined in the TGA International Engagement Strategy: Operation Plan 2018-19. These include international initiatives such as the International Coalition of Medicines Regulatory Authorities, the International Medical Devices Regulators’ Forum, the ACSS, the Pharmaceutical Inspection Cooperation Scheme (PIC/S), including working groups, as well as bilateral collaboration with other regulators.

The Department’s participation in PIC/S and subsequent adoption of updates into the Australian Code of Good Manufacturing Practice (GMP), in consultation with Australian manufacturers, resulted in a greater number of highly compliant manufacturers.

In addition to work-sharing initiatives and reliance mechanisms, the Department partnered with the Department of Foreign Affairs and Trade to implement the Indo-Pacific Regulatory Strengthening Program and the Pacific Medicines Testing Program. Both these programs seek through partnership arrangements to strengthen the capacity of regulators in these regions to work towards timely access to better quality medicines, and seek to reduce the incidence and impact of substandard and counterfeit medicines.

Case Study
Update to the Australia-Canada Mutual Recognition Agreement

On 8 November 2013, regulatory amendments for mandatory Good Manufacturing
Practices (GMP) of active pharmaceutical ingredients (API) intended for use in human drugs came into force in Canada. The implementation of these regulatory amendments enabled Health Canada to include APIs under the operational scope of its existing Mutual Recognition Agreements (MRAs).

In Australia, manufacturers of APIs are regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990. Australian API manufacturers are required to hold a GMP licence, unless specifically exempt.

As of 1 November 2018, Health Canada and the Therapeutic Goods Administration (TGA) of Australia established an agreement to include APIs under the scope of the Mutual Recognition Agreement on Conformity Assessment in Relation to Medicines Good Manufacturing Practice Inspection and Certification between Canada and Australia. As a result, the TGA now accepts GMP Certificates of Compliance (or equivalent) issued by Health Canada under this MRA, for APIs manufactured in Canada, in support of a GMP Clearance application.

Australian sponsors who source APIs from Canada will benefit from the new MRA pathway, which requires a reduced level of documentary evidence and a reduced processing time of 30 days. The previous pathway could take up to 120 working days to process.

Australian consumers benefit from the faster access to medicines that is provided from TGA’s international agreements and information sharing.

This image depicts a woman in a pharmacy reading the active pharmaceutical ingredients on a box of medicine.


Regulating the import, export, and manufacture of controlled drugs, and cultivation of medicinal cannabis

Access to medicinal cannabis products for use by eligible Australian patients is ensured by accessing and processing applications for the import, export and manufacture of controlled substances within agreed timeframes.

Source: 2018-19 Health Portfolio Budget Statements, p.123

2018-19 Target

2018-19 Result

2017-18

2016-17

2015-16

2014-15

>95%

97.0%

94.0%

98.0%

99.0%

85.0%

Result: Met

The Department issued 8,798 licences and permits authorising the import, export and manufacture of controlled drugs. This represented a 4 per cent decrease compared with 2017-18.

Processing applications within agreed timeframes ensures access to essential medicines by the Australian public and supports operations of Australian businesses involved in international and domestic trade of controlled substances.

The Department also issued 82 checks and statements to law enforcement in support of investigations into possible criminal importation.

Protecting people and the environment by assessing the risks of industrial chemicals and providing information to promote their safe use

Proportion of National Industrial Chemicals Notification and Assessment Scheme recommendations intended to protect people and the environment from the harmful effects of chemicals, which have been accepted following consideration by Commonwealth and State and Territory risk management agencies.

Source: 2018-19 Health Portfolio Budget Statements, p.123

2018-19 Target

2018-19 Result

2016-17

2015-16

2014-15

2013-14

≥80%

100%

99.6%

N/A

N/A

N/A

Result: Met

A total of 1,015 recommendations arising from chemical assessments were considered and accepted (in part or whole) by risk management agencies, including Safe Work Australia and the delegate of the Secretary of the Department of Health for maintaining the Poisons
Standard – Standard for the Uniform Scheduling of Medicines and Poisons.

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) assesses the risks arising from the introduction and use of industrial chemicals in Australia, and makes recommendations to agencies responsible for managing the use and disposal of chemicals. Recommendations provided by NICNAS assist in protecting human health and the environment from the risks associated with the introduction and use of industrial chemicals.

Proportion of known importers and manufacturers of industrial chemicals registered with the National Industrial Chemicals Notification and Assessment Scheme is increased, to promote awareness among the regulated community of their legal obligations.

Source: 2018-19 Health Portfolio Budget Statements, p.123

2018-19 Target

2018-19 Result

2017-18

2016-17

2015-16

2014-15

≥90%

98.0%

99.0%

N/A

N/A

N/A

Result: Met

All introducers (importers and manufacturers) of industrial chemicals are required to register with NICNAS each year. As a result of compliance monitoring activities that identify unregistered industrial chemicals introducers, 764 new introducers were registered with the scheme in 2018-19.

A sample of registered introducers was audited to monitor compliance with their obligations under the Industrial Chemicals (Notification and Assessment) Act 1989 (the Act) with respect to new chemicals, resulting in the identification of 41 chemicals that were subsequently notified or reported to NICNAS.

Notified chemicals are assessed by NICNAS for their potential risks to human health and the environment and recommendations to promote their safe use are provided to other risk managers. Registration provides NICNAS with current information about the introduction of industrial chemicals and delivers transparency to the public and industry regarding introducer identity.

Registered introducers are provided with information that improves their awareness of and compliance with obligations under the Act.

Compliance monitoring focuses on ensuring all introducers of the relevant industrial chemicals are registered with NICNAS and comply with obligations of the Act, including notification of new industrial chemicals and provision of chemical information.

Proportion of National Industrial Chemicals Notification and Assessment Scheme risk assessments completed within statutory timeframes to provide the Australian community with timely access to information about the safe use of new chemicals and support innovation by Australian businesses.

Source: 2018-19 Health Portfolio Budget Statements, p.124

2018-19 Target

2018-19 Result

2017-18

2016-17

2015-16

2014-15

≥95%

98.7%

99.0%

99.6%

99.0%

98.0%

Result: Met

During 2018-19, the Department completed a total of 227 pre-market assessments of new chemicals, with 224 of these completed within statutory timeframes. Assessment quality is maintained through internal peer review and stakeholder feedback prior to finalising all reports. No applications concerning the outcomes of chemical assessments were submitted to the Administrative Appeals Tribunal for review.

Adherence to statutory timeframes promotes timely availability of new chemicals to the community and provides regulatory certainty for industry.

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

People and the environment are protected through open, effective and transparent regulation of genetically modified organisms.

Source: 2018-19 Health Portfolio Budget Statements, p.124

2018-19 Target

2018-19 Result

Risk assessments and risk management plans prepared for licence applications and all decisions made within the statutory timeframes.

Stakeholders, including the public, consulted on all assessments for proposed release of GMOs into the environment.

High level of compliance with gene technology legislation and no adverse effect on human health or environment from authorised GMOs.

Risk assessment and management plans were prepared, and decisions made within statutory timeframes, for 100% of licenced dealings.

Stakeholders, including the public, were consulted on all assessments for proposed release of GMOs into the environment.

There was a high level of compliance with gene technology legislation, with no evidence of any adverse effect on human health or the environment from authorised GMOs.

Result: Met

The Office of the Gene Technology Regulator has skilled technical staff to conduct science based risk assessments. There are project management structures for all licence applications, including timeframe and quality assurance reporting, with public consultation procedures built into relevant decision-making processes.

The following licences were issued during 2018-19:

  • five licences for genetically modified (GM) crop trials;
  • two licences to import GM grain for stockfeed;
  • four licences for trial of GM vaccines against viral diseases;
  • two licences for trial of GM virus-based cancer treatments;
  • one licence for gene therapy for treatment of a genetic disorder; and
  • three licences for pre-clinical (in vitro and animal) research into understanding and treating human diseases.

Monitoring and compliance inspections confirmed a high level of compliance with licence and certification requirements. Stakeholders are continuing to work with inspectors using a cooperative compliance approach.

In June 2019 there were:

  • 11 active clinical trial licences for human therapeutics;
  • four commercial licences for human therapeutics;
  • three active licences for animal vaccines;
  • 55 field trial sites for GM crops; and
  • 126 active licences and 3,275 notifications for scientific research conducted in over 2,000 facilities certified as appropriate for work with GMOs.

The Gene Technology Regulatory Scheme ensures that medical, agricultural and other research involving GMOs is conducted in accordance with best practice and in a manner that protects human health and safety and the environment. The scheme facilitates the safe conduct of medical research with the potential to lead to new effective preventions and treatments for a range of significant diseases.

The scheme also facilitates safe conduct of field trials of GM crops for enhanced disease or drought resistance for crop production and improved nutritive value. The scheme also ensures that all GMOs are subject to a scientifically rigorous risk assessment that must be completed prior to release into the Australian environment. Regular public consultation provides transparency and allows individuals to provide information relevant to risk assessments. This enables the community to safely access GMOs and products produced from GMOs.

Protecting the health of people and the environment through effective regulation

Existing frameworks are strengthened to ban cosmetic testing on animals.

Source: 2018-19 Health Portfolio Budget Statements, p.125

2018-19 Target

2018-19 Result

Continue to work with the National Health and Medical Research Council (NHMRC) and states and territories to incorporate a cosmetic testing ban through state and territory legislation in line with the National Health and Medical Research Council Australian Code for the care and use of animals for scientific purposes 8th edition (2013).

Parliament to consider Animal Cosmetic Testing Ban legislation as part of the new Industrial Chemicals Bill 2017.

Undertake procurement and commence work program to develop a voluntary Industry Code of Practice and a product information and communication package.

The NHMRC commenced work on amendments to the Animal Ethics Code.

The Industrial Chemicals Act 2019 (IC Act 2019) received Royal Assent in March 2019. The new Australian Industrial Chemicals Introduction Scheme (AICIS) will come into effect on

1 July 2020. It will implement the legislative component of the Government’s commitment to ban testing of cosmetic ingredients on animals.

Work on a voluntary Industry Code of Practice and product information and communication package is underway.

Result: Met

Amendments to the Animal Ethics Code are expected to be completed prior to the commencement of the legislative ban on 1 July 2020.

Following commencement on 1 July 2020, the IC Act 2019 will give effect to the ban on the use of new animal test data for ingredients used solely in cosmetics. The IC Act 2019 will be supported by delegated legislation, which will set out technical and operational details of the new scheme and the requirements for introducers, including details in relation to the ban.

It is expected that the voluntary Industry Code of Practice will be developed to coincide with the commencement of the legislative ban and will be complemented by communication activities. The ban will improve animal welfare in Australia while maintaining Australia’s strong human health and environmental protection standards.

Program 5.2: Health Protection and Emergency Response

The Department met all performance targets related to this program.

The Department continued to strengthen its capabilities and capacity in responding to public health and safety threats and emergencies. The Department aims to protect Australia from communicable diseases, natural disasters, terrorism and other incidents that may lead to mass casualties.

The Five National Blood Borne Viruses (BBV) and Sexually Transmissible Infections (STI) Strategies 2018–2022 were endorsed by the Council of Australian Governments’ (COAG) Health Council (CHC) in late 2018. The importance of and commitment to achieving these strategies is apparent through the high levels of stakeholder engagement.

Implementation of Australia’s National Action Plan for Health Security (NAPHS), which was published in December 2018, will continue to be a key priority for the Department.

The National Antimicrobial Resistance (AMR) Strategy continued to be a major focus of the Department. Programs under the AMR Strategy 2015–2019 are ongoing until the end of 2019, with a 2020 and beyond strategy currently being developed.

During 2018-19, mosquito suppression strategies effectively prevented growth or expansion of the residual population of exotic mosquitos, resulting in no detections of the exotic mosquito in surveys conducted on the mainland of Australia.

Reducing the incidence of blood borne viruses and sexually transmissible infections

National direction supports a coordinated response to reducing the spread of blood borne viruses (BBV) and sexually transmissible infections (STI).

Source: 2018-19 Health Portfolio Budget Statements, p.127

2018-19 Target

2018-19 Result

All partners, including States and Territories, clinicians, researchers, and community and professional organisations are supported to reduce the incidence of BBV and STI in the community with a focus on Aboriginal and Torres Strait Islander BBV and STI through:

  • Monitoring progress against the programs that support the new National BBV and STI Strategies 2018-2022, in accordance with respective implementation plans.
  • Surveillance and monitoring of progress against targets and goals including estimates of incidence and prevalence.

Five National BBV and STI Strategies 2018–2022 were endorsed by CHC in late 2018. The strategies are the:

  • Eighth National HIV Strategy;
  • Fifth National Hepatitis C Strategy;
  • Third National Hepatitis B Strategy;
  • Fourth National STI Strategy; and
  • Fifth National Aboriginal and Torres Strait Islander BBV and STI strategy.

The Fifth National Aboriginal and Torres Strait Islander BBV and STI strategy was also endorsed by the former Minister for Indigenous Health, the Hon Ken Wyatt AM, MP. Implementation plans have been developed for each of the five strategies, which guide actions and allow monitoring of progress towards the targets and goals of the strategies. They will be endorsed by the Australian Health Protection Principal Committee in mid 2019-20.

Result: Met

The strategies were informed by extensive consultations with stakeholders. Workshops were held in all capital cities, as well as selected regional areas. Topic specific workshops were also held with relevant stakeholders.

The Department considers that the significant stakeholder engagement in the development of these strategies, and continued high level of engagement in their implementation, indicates a high level of commitment to achieving the strategic objectives, goals and targets within the strategies.

Together the strategies set out goals and targets under the broad headings of:

  • education and prevention;
  • testing, treatment and management;
  • equitable access and coordination of care;
  • workforce;
  • addressing stigma and creating an enabling environment; and
  • data, surveillance, research and evaluation.

The strategy goals and targets focus on significantly reducing the transmission of BBV and STI, increasing diagnosis and treatment rates, facilitating a highly skilled and collaborative workforce and improving the quality of life for people living with a BBV and/or STI.

The Department will continue working with community and other stakeholders to achieve the goals and targets identified in the strategies.

Providing an effective response to national health emergencies, improving biosecurity and minimising the risks posed by communicable diseases

National health emergencies and emerging health protection issues are managed and responded to through effective preparation and mitigation measures.

Source: 2018-19 Health Portfolio Budget Statements, p.128

2018-19 Target

2018-19 Result

Implement and maintain compliance with the World Health Organization International Health Regulations (2005) (IHR).

Implement recommendations from the Joint External Evaluation (JEE) to strengthen Australia’s health security.

Successfully respond to and manage health emergencies through the timely engagement of national health coordination mechanisms and response plans.

Collect and disseminate data in the National Notifiable Diseases Surveillance System, including publishing on the Department’s website to keep the community informed.

Australia’s NAPHS was published in December 2018. The NAPHS provides a five year framework for implementing the 66 recommendations of the 2017 JEE to strengthen Australia’s health security and compliance with the World Health Organization’s IHR.

Of the 66 recommendations, 11 (16.5%) have been completed and work is underway on 34 (51%). While 21 (32%) have not yet been started, the NAPHS is a five year plan and this is expected.

Australia is expected to report on NAPHS implementation in five years, at which time countries are expected to complete another JEE.

There were no reports of actual or suspected data breaches of the Biosecurity Act 2015 in relation to the use of protected information. There has been one written authorisation to disclose protected information under section 580(3) of the Biosecurity Act 2015.

The Department’s National Incident Room (NIR) continued to support the Australian National Focal Point under the IHR. The NIR responded to approximately 20 public health incidents per month. The three most common hazards notified to the NIR, accounting for over two thirds of the year’s incidents, were tuberculosis, measles and legionellosis.

Over this reporting period, 160 incidents involved the use of protected information within the meaning of section 18 of the National Health Security Act 2007.

Result: Met

The NAPHS was developed in consultation with a range of agencies at all levels of government, particularly the Department of Agriculture and state and territory health departments. The NAPHS was published within 12 months of completion of Australia’s JEE Mission.

The overall number of national public health incidents increased by approximately 40 per cent in 2018-19, compared to 2017-18. Major drivers of the increase were importations of measles cases, up by approximately 60 per cent, and overseas acquisitions of Legionnaires’ disease, up by approximately 40 per cent. Throughout 2018-19, data was made available to stakeholders and researchers upon request. Daily aggregated data were updated and made available on the Department’s website.

On a larger scale, the NIR provided the capability to coordinate national responses to health emergencies and health aspects of other emergencies. Major incidents in 2018-19 included several severe weather events and international outbreaks of Ebola virus disease, measles and polio.

Australia’s health security and IHR capacity continued to be maintained and built on through implementation of the NAPHS. Examples include:

  • enhancing emergency response capabilities by integrating multisectoral, multi-jurisdictional and all-hazard elements into the public health exercise program;
  • improving linkages between animal and human health under a One Health approach to promote better collaboration and coordination of activities;
  • continuing to effectively manage bio-risks of natural and intentional causes; and
  • continuing to maintain a comprehensive system of border measures to reduce risks of importation of pathogens and pests.

The Australian community benefits from efficient national coordination of public health events of national significance, enabling public health authorities to rapidly identify and respond to individuals who are at risk of communicable diseases, and by supporting national consistency of health sector preparedness and response efforts to emergencies.

Ensuring the availability of high quality and publicly accessible communicable disease notification data and analyses is an important part of mitigating the public health impacts associated with these diseases.

National direction to minimise the spread of antimicrobial resistance (AMR) is provided.

Source: 2018-19 Health Portfolio Budget Statements, p.128

2018-19 Target

2018-19 Result

Action against the spread of AMR is supported through ongoing implementation of programs that support the National AMR Strategy 2015-2019.

A number of programs that support the National AMR Strategy 2015–19 continue to be implemented. This includes:

  • the Antimicrobial Use and Resistance in Australia (AURA) Surveillance System;
  • commencing Australia’s contribution to the World Health Organization’s Global Antimicrobial Resistance Surveillance System (GLASS);
  • work to support general practice (GP) stewardship;
  • ongoing improvements to the One Health AMR website; and
  • the development of the next AMR Strategy 2020 and beyond.

Result: Met

Throughout 2018-19, ongoing efforts have been made to reduce the impact of AMR.

The AURA Surveillance System continues to coordinate human health data from a range of sources, which allows for integrated analysis and reporting of AMR and antibiotic use at a national level. Australia has also recently commenced its contribution of AMR data from the Gonococcal Surveillance Programme to GLASS.

Minimising AMR will require an ongoing concerted effort by all sectors and it is likely to take time before improving AMR trends are observed.

Programs implemented under the National AMR Strategy 2015–19 will benefit the community through minimising the development and spread of AMR and ensuring continued availability of effective antimicrobials.

AMR is a serious global issue that requires urgent action. The rise and spread of AMR is creating a new generation of resistant bugs that cannot be treated with existing medicines. International collaboration and commitments on AMR are occurring through organisations including the United Nations and G20. A 2018 Organisation for Economic Co-operation and Development report estimated that by 2050, health care costs in Australia due to AMR could reach $370 million.

Australia’s defences against the potential spread of mosquito-borne diseases on mainland Australia and in the Torres Strait are supported.

Source: 2018-19 Health Portfolio Budget Statements, p.129

2018-19 Target

2018-19 Result

Undertake targeted vector surveillance and control programs in the Torres Strait.

Work closely with the Department of Agriculture and Water Resources and States and Territories, on exotic vector surveillance and control at Australia’s international airports and seaports.

Provision of surveillance reports continued to confirm the suppression of exotic mosquito populations in the Torres Strait. There were no detections of the targeted exotic mosquito on mainland Australia in 2018-19.

The program to protect Australia by preventing expansion of areas infested with the exotic mosquito, Aedes albopictus, has remained successful during 2018-19.

Several exotic mosquitoes were detected through trapping and specimen analysis during 2018-19. In all cases, effective chemical treatments were implemented.

Result: Met

Focus was maintained on suppression of the exotic mosquito on the strategic transport hubs of Horn Island and Thursday Island. The intensive control and monitoring activities on these islands in recent years have resulted in near elimination, such that the species have been undetectable in most of the surveys conducted.

Mosquito suppression strategies effectively prevented growth and expansion of the residual population of exotic mosquitoes.

The Department worked closely with the Department of Agriculture and states and territories to implement measures at Australia’s air and sea ports to prevent the incursion of exotic mosquitoes at the border and the subsequent establishment of breeding populations in Australia. These measures include:

  • chemical treatment of all aircraft entering Australia;
  • monitoring of exotic mosquito incursions through trapping and specimen analysis;
  • vector control at Australian air and sea ports, including residual chemical treatments, chemical fogging for adult mosquitoes and chemicals applied to standing water to treat mosquito larvae; and
  • the continued control of exotic mosquito populations in the Torres Strait has reduced the risk of dengue and other mosquito-borne diseases in the Torres Strait.

Exotic mosquitoes and vector-borne diseases present a public health risk to Australia. Several factors including increased international travel and trade, increased urbanisation and changing climate have increased the risk and distribution of mosquitoes and the viruses they carry.

Australia is largely maintaining freedom from the exotic mosquitoes which can carry and spread yellow fever, dengue, malaria, chikungunya and Zika viruses, thus saving our population from a significant potential disease burden.

In 2018-19, mainland Australia remained free of Aedes albopictus populations and Aedes aegypti populations remain confined to parts of Northern, Central and Southwest Queensland.

Program 5.3: Immunisation

The Department substantially met all performance targets related to this program.

Immunisation coverage rates in children at five years of age remains high through the National Immunisation Program (NIP), indicating a high level of protection in the community. In February 2019, the Department published the National Immunisation Strategy for Australia 2019–2024 which comprises eight priority areas which aim to strengthen and complement the NIP. These priorities are: improve immunisation coverage; ensure effective governance of the NIP; ensure secure vaccine supply and efficient use of vaccines for the NIP; continue to enhance vaccine safety monitoring systems; maintain and ensure community confidence in the NIP; strengthen monitoring and evaluation of the NIP; ensure an adequately skilled immunisation workforce and maintain Australia’s strong contribution to the region.

The Department is working hard to close the gap for Aboriginal and Torres Strait Islander Australians through increasing vaccination coverage rates. In April 2019, the Department launched the third phase of the Childhood Immunisation Education Campaign. This phase of the campaign included a comprehensive public relations strategy for Aboriginal and Torres Strait Islander Australians, promoting the importance of vaccinating on time. This strategy included the development of educational videos, posters, and print and radio stories distributed through Aboriginal Medical Services and Aboriginal Community Controlled Health Organisations.

The Department is also raising awareness of the Adolescent Meningococcal ACWY vaccine. From 1 April 2019, the vaccine is provided for free to Year 10 Students (14–16 years of age) through school-based programs. If adolescents between 15–19 years of age miss out on the vaccine at school, they can access it through their general practitioner or primary care provider.

Seasonal influenza vaccines

In 2018-19, the Department effectively implemented a comprehensive seasonal influenza program, ensuring the most vulnerable in the community were provided with a free seasonal influenza vaccine through the NIP. These groups included those at increased risk of contracting seasonal influenza, those aged 65 years and older, pregnant women and, for the first time in 2019, all Aboriginal and Torres Strait Islander Australians aged 6 months and older. This has reduced the previous gap in eligibility for those aged 5–14 years.

The 2019 influenza season saw a record number of seasonal influenza vaccines released for the Australian market, with almost 13.2 million doses made available. This included over 3.8 million doses of an enhanced seasonal influenza vaccine specifically formulated for those aged 65 years and older. This ensured that enough vaccines were available for close to 95 per cent of all Australians aged over 65.

Case Study
Protecting pregnant women and their babies through maternal vaccination

Launched in March 2019, the Maternal Vaccination campaign encourages vaccination during pregnancy as a safe, effective way to protect pregnant women and their babies against influenza and pertussis (whooping cough). Vaccines are provided free through the National Immunisation Program.

Despite vaccination against both influenza and whooping cough being recommended to pregnant women for several years, estimates of vaccination uptake indicated improvements could be achieved.

Research conducted in 2018 identified the opportunity for communications to positively influence pregnant womens’ decision to vaccinate, with different messaging required for each vaccination.

The whooping cough vaccine is already widely accepted by pregnant women as part of their pregnancy care and campaign materials aim to reinforce the benefits of timely whooping cough vaccination during pregnancy.

Catherine Hughes, who experienced the devastating loss of her son to whooping cough, features in the campaign materials.

Getting vaccinated during pregnancy reduces the chance of a newborn contracting whooping cough by around 90 per cent.” – Catherine Hughes

Pregnant women are far less certain about getting the influenza vaccine. There was a need to raise awareness of the seriousness of influenza for pregnant women and their babies, promote the benefits of vaccination and address potential safety concerns.

The campaign reaches pregnant women and their partners through online communication channels including social media, online video and Google searches. Public relations materials including printed resources and materials for health care providers have also been distributed as part of the campaign.

 Protecting your baby against influenza and whooping cough starts when you’re pregnant.


Increasing national immunisation coverage rates and improving the effectiveness of the National Immunisation Program

Immunisation coverage rates in children at 5 years of age are increased.3

Source: 2018-19 Health Portfolio Budget Statements, p.130 and Health Corporate Plan 2018-19, p.11

2018-19 Target

2018-19 Result

2017-18

2016-17

2015-16

2014-15

≥94.25%

94.90%

94.40%

93.60%

92.90%

92.30%

Result: Met

Immunisation coverage rates have continued to increase in 2018-19. This trend is expected to continue towards the World Health Organization Western Pacific Region, Chief Medical Officer’s and Chief Health Officers’ target coverage rate of 95 per cent. The Department will continue to work with states and territories to achieve this target.

Through the delivery of the NIP, childhood immunisation rates continue to improve, indicating a high level of protection in the Australian community.

Increased immunisation rates protect the community as a whole. When enough people in the community are immunised, it is more difficult for these diseases to spread. This helps protect people who are more at risk of contracting a disease, including unvaccinated members of our community. This means that even those who are too young or too sick to be vaccinated will not encounter the disease. This is called ‘herd immunity’.

Immunisation coverage rates among 12-15 months of age Aboriginal and Torres Strait Islander children are increased.4

Source: 2018-19 Health Portfolio Budget Statements, p.130 and Health Corporate Plan 2018–19, p.11

2018-19 Target

2018-19 Result

2017-18

2016-17

2015-16

2014-15

≥92.50%

92.40%

92.50%

92.20%

89.80%

N/A

Result: Substantially met

Immunisation coverage rates among Aboriginal and Torres Strait Islander children at 12–15 months of age has decreased slightly, to 92.4 per cent in 2018-19, from 92.5 per cent in 2017-18. While the target rate set for 2018-19 has not been met, there has been significant gains in the coverage rate in this cohort in recent time (up from 89.8 per cent in 2015-16).

Even though there has been an increase over time in immunisation coverage rates for Aboriginal and Torres Strait Islander children at 12–15 months of age, a significant gap still remains and further work is required to reduce this disparity.

The Department continued to promote timely vaccination for Aboriginal and Torres Strait Islander children through the development and dissemination of engaging, targeted information to address the gap in immunisation coverage rates between Indigenous and non-Indigenous children in the younger age groups.

This is further supported by performance benchmarks in the National Partnership Agreement on Essential Vaccines, including for improving coverage rates among Aboriginal and Torres Strait Islander children.

Outcome 5 - Expenses and Resources

Budget Estimate 2018-19

$’000 (A)

Actual 2018-19

$’000 (B)

Variation

$’000

(B) - (A)

Program 5.1: Protect the Health and Safety of the Community through Regulation

Administered expenses

Ordinary annual services (Appropriation Act No. 1)

-

-

-

Departmental expenses

Departmental appropriation1

17,424

15,889

(1,535)

to Special Accounts

(10,094)

(10,094)

-

Expenses not requiring appropriation in the budget year2

243

272

29

Special Accounts

OGTR3

7,638

7,377

(261)

NICNAS4

19,124

17,049

(2,075)

TGA5

154,774

158,562

3,788

Expense adjustment6

249

518

269

Expenses not requiring appropriation in the budget year2

-

2

2

Total for Program 5.1

189,358

189,575

217

Program 5.2: Health Protection and Emergency Response7

Administered expenses

Ordinary annual services (Appropriation Act No. 1)

97,739

88,080

(9,659)

Non cash expenses8

23,508

23,570

62

Special Accounts

Human Pituitary Hormones Special Account (s78 PGPA Act)

170

246

76

Departmental expenses

Departmental appropriation1

25,996

25,169

(827)

Expenses not requiring appropriation in the budget year2

929

1,223

294

Total for Program 5.2

148,342

138,288

(10,054)

Program 5.3: Immunisation7

Administered expenses

Ordinary annual services (Appropriation Act No. 1)

36,169

35,540

(629)

to Australian Immunisation Special Account

(7,133)

(7,161)

(28)

Special Accounts

Australian Immunisation Register Special Account (s78 PGPA Act)

9,820

9,499

(321)

Special appropriations

National Health Act 1953

- essential vaccines

353,162

333,712

(19,450)

Departmental expenses

Departmental appropriation1

8,779

8,523

(256)

Expenses not requiring appropriation in the budget year2

287

388

101

Total for Program 5.3

401,084

380,501

(20,583)

Outcome 5 totals by appropriation type

Administered expenses

Ordinary annual services (Appropriation Act No. 1)

133,908

123,620

(10,288)

to Special Accounts

(7,133)

(7,161)

(28)

Non cash expenses8

23,508

23,570

62

Special Accounts

9,990

9,745

(245)

Special appropriations

353,162

333,712

(19,450)

Departmental expenses

Departmental appropriation1

52,199

49,581

(2,618)

to Special Accounts

(10,094)

(10,094)

-

Expenses not requiring appropriation in the budget year2

1,459

1,883

424

Special Accounts

181,785

183,508

1,723

Total expenses for Outcome 5

738,784

708,364

(30,420)

Average staffing level (number)

1,098

1,012

(86)

1 Departmental appropriation combines ‘Ordinary annual services (Appropriation Act No. 1)’ and ‘Revenue from independent sources (s74)’.

2 Expenses not requiring appropriation in the budget year are made up of depreciation expense, amortisation, make good expense, operating losses and audit fees.

3 Office of the Gene Technology Regulator Special Account.

4 National Industrial Chemicals Notification and Assessment Scheme Special Account.

5 Therapeutic Goods Administration Special Account.

6 Special accounts are reported on a cash basis. The adjustment reflects the difference between expense and cash, and eliminates inter-entity transactions between the core Department and TGA.

7 This Program excludes National Partnership payments to state and territory governments by the Treasury as part of the Federal Financial Relations (FFR) Framework.

8 Non cash expenses relate to the write down of drug stockpile inventory due to expiration, consumption and distribution.