Major Achievements
- Contributed to a raised awareness and early detection of bowel cancer by distributing over 400,000 screening invitations to eligible Australians in all states and territories.
- Helped protect women from cervical cancer by implementing the National Human Papillomavirus Vaccination Program in conjunction with State and Territory governments.
- Changed the gene technology regulatory framework to ensure that Australia is best placed to encourage ongoing research and development.
- Combated the abuse of kava in Indigenous communities by enforcing import regulations.
- Facilitated stakeholder comment on the proposed Trans Tasman Therapeutic Products Regulatory Scheme through an extensive consultation process.
- Helped reduce regulatory duplication, burden or cost to manufacturers of therapeutic goods by working with international organisations and aligning policies, regulatory frameworks and standards with international standards.Top of Page
Challenge
- Continued negotiations between the Australian and New Zealand Governments to establish the Trans Tasman Therapeutic Products Regulatory Scheme. Difficulties were experienced in ensuring the implementing legislation was consistent with the Treaty between the two countries and supported existing public health and safety standards in Australia. Top of Page
Key Strategic Directions for 2006–07
Focus on the Main Lifestyle Causes of Preventable Disease
Implementation of the Australian Better Health Initiative
During 2006–07, the Department continued to provide national leadership in an effort to reduce lifestyle health risk factors associated with overweight, obesity and chronic disease. Working in conjunction with the states and territories, the Department coordinated and finalised a detailed jurisdictional implementation plan for the Council of Australian Governments’ (COAG) Australian Better Health Initiative. It also commenced a number of associated activities which focused on reducing obesity and physical inactivity. These included the Healthy Active Ambassador Program which engaged well-known Australians such as Harry Kewell, Brett Lee and Layne Beachley as official ambassadors to promote the benefits of healthy life choices to the community, and the ‘Healthy Active Australia’ Community and School Grants Program. Through this initiative, eligible community organisations can receive grants to conduct healthy eating and/or physical activity projects at the local level across Australia. The Department advertised the grants in 2006–07. Discussion on other Australian Better Health Initiative activities can also be located in the Outcome 5 and Outcome 10 chapters.
Healthy School Communities
The Department also continued to manage the Healthy School Communities program, which promotes healthy eating in schools, under the Building a Healthy Active Australia Initiative. All primary and secondary schools across Australia were invited to participate, and the Department approved 6,986 grants over the life of the program. The most popular projects were canteen and classroom-based activities linked to vegetable garden projects, community education and event-based activities such as fruit and vegetable tastings, and expos to improve the quality and range of nutritious foods available.
Combating Smoking and Alcohol Misuse
New national initiatives to reduce smoking rates, prevent youth uptake and reduce risky and high-risk drinking were introduced in 2006–07. The Department launched the National Tobacco Youth Campaign in December which included a series of television, radio and print advertisements run during the 2006–07 Christmas and New Year period and again throughout February and March 2007. This campaign was specifically developed to help reduce the uptake and prevalence of smoking among young Australians aged between 12 and 24 years. It was also aimed at parents who smoke.
In addition, the Department commenced a range of new initiatives focusing on education and responsible consumption of alcohol. This included distributing approximately two million alcohol-related health promotion resources to the Australian community. The resources aim to improve community understanding of low risk drinking levels and promote a more responsible drinking culture in Australia.
Lifescripts
The Department provided funding for the development of a Pregnancy Lifescripts Kit to help women have healthy pregnancies and healthy babies through a focus on the key risk factors for pregnancy – tobacco, alcohol use and nutrition. The kit was developed by a consortium led by the Australian General Practice Network and was designed for use by general practitioners and practice nurses. The kit was completed and distributed in June 2007. Funding was also provided to the James Cook University to adapt Lifescript resources for use with Aboriginal and Torres Strait Islander patients and patients from culturally and linguistically diverse backgrounds; and to develop software to make the Lifescripts resources available electronically from a range of clinical desktop systems used in general practice.
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Disease Prevention and Protection
Bowel Cancer Screening
Work continued in 2006–07 towards the early detection and prevention of disease. The Department continued to provide funding for the development of new screening initiatives and to maintain existing screening initiatives. In August 2006, the Department commenced the first phase of a National Bowel Cancer Screening Program. Bowel cancer is the second most common internal cancer affecting Australians and the second-highest cause of cancer-related death in Australia. Introduction of this important initiative will effectively reduce the incidence of bowel cancer-related deaths in Australia through early detection and treatment.
During the year, over 400,000 invitations to screen were sent to eligible Australians in all states and territories. Despite some delays to commencement in some states and territories, as at 30 June 2007 the crude participation rate for the program (the number of faecal occult blood test kits received as a proportion of people invited) was 36 per cent. A program register is tracking participants through the screening pathway for the program. In the first nine months, data reported to the register indicated that 29 cancers and 44 adenomas had been detected.
Protection from Cervical Cancer
Since the inception of the National Cervical Screening Program in 1991, incidence rates of cervical cancer for women 20 to 69 years have fallen from 17.2 cases per 100,000 population to 9.1 per 100,000 population in 2003. This represents a reduction of approximately 47 per cent.1 The National Human Papillomavirus Vaccination Program announced by the Government in November 2006 will further reduce the incidence of cervical cancer in Australia. The vaccine will protect women against certain strains of the virus known to cause 7 out of 10 cases of cervical cancer and 9 out of 10 cases of genital warts. Under this program, the vaccine is currently being provided free to young women and girls aged 12 to 26 years. From November 2006, the Department worked in conjunction with the states and territories to develop a national implementation process for the introduction of the new vaccine. The program commenced nationally in April 2007, with the Department providing funding to each of the states and territories to implement the program.
Immunisation
Notification rates for vaccine preventable diseases in Australia are historically low due to the high levels of vaccination coverage amongst the age groups targeted by the National Immunisation Program. For example, rates of meningococcal C disease have continued to decline. In 2002 there were 213 cases of meningococcal C disease reported; in 2005 this had dropped to 40 cases (a decrease of 81 per cent). The Department continued to provide funding to the program in 2006–07 and prepared for the introduction of a free rotavirus vaccine for all children born on or after 1 May 2007.
Research support was also a priority in 2006–07. The Department increased funding for the National Centre for Immunisation Research and Surveillance to undertake research and evaluation of immunisation programs and surveillance of vaccine preventable diseases. The Department also provided funding for the Australian Childhood Immunisation Register to collect and report on the vaccination status of Australian children.
HIV/AIDS and Sexually Transmissible Infections
Compared with 2004, the most recently available data for 2005 indicate that notifications for HIV/AIDS and Sexually Transmissible Infections have increased in Australia by 9.3 per cent for HIV/AIDS, 14 per cent for chlamydia, 11.5 per cent for gonorrhoea and 5.5 per cent for syphilis. Increased notifications in HIV and Sexually Transmissible Infections are not confined to Australia but have been noted worldwide.
In 2006–07, the Department continued to implement national HIV/AIDS, Sexually Transmissible Infections and Hepatitis C strategies. It completed a review of the National HIV Testing Policy which recommended a number of changes including the routine offer of HIV testing to all pregnant women. The primary aim of this is to prevent mother to child transmission of HIV. A revised testing policy was endorsed by the Ministerial Advisory Committee on AIDS, Sexual Health and Hepatitis in 2006–07 and included review recommendations. A mid-term review of the implementation of the National Strategies was also completed.
The Department also continued to raise awareness and surveillance of chlamydia, providing funding to 15 chlamydia testing and awareness activities projects in a range of settings in urban, rural and remote Australia. Other funded projects included comprehensive national surveillance of chlamydia, and chlamydia education for a range of professionals, including general practitioners, nurses, and teachers. The Department also started to develop a pilot testing program, which will be conducted in general practice pilot sites in early 2008.
National Pregnancy Support Helpline
In 2006–07, the National Pregnancy Support Helpline was established to improve the availability of timely, confidential, professional pregnancy counselling for Australian women and their partners, including those in rural and remote areas. The helpline provides non-directive counselling on all available options which aims to assist people in making their own decisions on the course they wish to take. The Department undertook open tender processes for provision of the helpline and development of a training program for helpline counsellors in late 2006. Family Planning WA was engaged to develop the training program. In January 2007, McKesson Asia Pacific Pty Ltd was engaged by the Department to implement the helpline service and develop an evidence-based information manual for helpline counsellors. The Department established an Expert Advisory Committee to oversee development of the information manual and training program. These resources have been finalised and approved by the committee. Commencement of the Helpline on 1 May 2007 has provided an added dimension to the support mechanisms available for women, their partners and their families who are concerned about a pregnancy.
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Reducing the Demand, Supply and Harm Caused by Illicit Drugs
During 2006–07, the Department introduced new initiatives targeting the increased use of pyschostimulants and cannabis. A national consortium, led by the National Drug and Alcohol Research Centre was selected to establish and operate a new National Cannabis Control and Prevention Centre. The centre will focus on community education, engaging young people and workforce support.
There was also a focus on reducing the problems caused by illicit drugs in Australia through the prevention, treatment and diversion components
of the Government’s Tough on Drugs Initiative. The Department provided funding to numerous community-based organisations through the Community Partnerships Initiative to implement a broad range of drug prevention activities. This initiative encourages ownership and participation in locally developed interventions and solutions to assist in the prevention and reduction of illicit drug use. The Department also supported approximately 120 non-government organisations to operate a range of alcohol and drug treatment services through the Non-Government Organisation Treatment Grants Program. Furthermore, the Department contributed to diverting non-violent drug offenders away from the criminal justice system and into assessment, education and treatment services, through the Illicit Drug Diversion Initiative.
During 2006–07, there was increasing public and Government concern about rises in the use of dangerous psychostimulants, especially crystal methamphetamine or ‘Ice’. The Department has introduced a number of measures under the National Psychostimulants Initiative aimed at combating the use of illicit psychostimulants and assisting health professionals in dealing with the consequences of their use. These add to the ongoing development of new treatment options and resources for frontline workers which have been a feature of the initiative since 2003–04. During 2006–07, guidelines were completed for ambulance services and emergency departments to assist them in dealing with people suffering from psychostimulant toxicity including psychosis, which is strongly associated with the use of Ice. Also, the Department took the lead in developing the National Amphetamine-Type Stimulants Strategy, which is expected to be completed in late 2007 and will provide a national framework for coordinating health and law enforcement responses to psychostimulants such as ‘Ice’.
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Improving National Population Health Capacity
Public Health Education and Research
In 2006–07, the Department implemented the new phase of the Public Health Education and Research Program to ensure that Australia continues to strengthen the capacity of the national public health workforce. This involved developing new program funding agreements which strengthen accountability requirements. Contestable agreements focused on emerging population health priorities including Indigenous health, biosecurity and disaster response, physical activity and nutrition, and other emerging health priorities. In addition, the Department continued to work with stakeholders to develop and implement a National Quality Framework for the program which aims to improve the capabilities of the public health workforce.
Mental Health
The national roll-out of the ‘Can Do’ Initiative: Managing Mental Health and Substance Use in General Practice project commenced, promoting a ‘can do’ approach to general practice to meet the challenge of mental health and substance use. Funded under the National Comorbidity Initiative, the project focuses on education, training and networking between two multidisciplinary teams of health professionals – general practice teams and community health teams (especially those engaged in alcohol and drug service, community pharmacy and mental health service delivery). The Department also supported the dissemination of the
PsyCheck mental illness screening tool across thirteen sites nationally.
PsyCheck is a comprehensive package that was developed to better assist drug and alcohol workers with mental illness identification and ultimately improve treatment outcomes.
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Establishment of the Trans Tasman Therapeutic Products Regulatory Scheme
Work continued during the year towards the establishment of the Trans Tasman Therapeutic Products Regulatory Scheme. Activities included an extensive consultation program to enable stakeholders to review and comment on the Australian implementing legislation and the Ministerial Council Rules for the joint regulatory scheme.
The Department released a series of consultation documents detailing the proposed regulatory framework. These included key documents addressing medicines scheduling provisions, product vigilance arrangements, the regulation of blood and human cellular and tissue therapies, advertising arrangements, and the regulation of in-vitro diagnostic devices. Focus group workshops were convened in Australia and New Zealand to enable stakeholders to hear about the proposed regulatory scheme, ask questions and provide preliminary feedback. Submissions were invited from industry, consumers and other interested stakeholders.
These activities culminated in an exposure draft of the Australian implementing legislation which was released for consultation in April 2007. The Therapeutic Products Bill 2007 was intended to establish the Australia New Zealand Therapeutic Products Authority to administer the therapeutic products regulatory scheme. A number of submissions were received from stakeholders. These comments were to be considered in the context of finalising the Bill.
The Department, through the Therapeutic Goods Administration and Medsafe (the New Zealand Medicines and Medical Devices Safety Authority) also made steady progress during 2006–07 in developing the shared corporate infrastructure required to support the operations of the proposed authority.
On 16 July 2007, the New Zealand Government announced that it would not proceed with the legislation designed to enable the establishment of a joint agency with Australia for the regulation of therapeutic products at this time. Both the Australian and New Zealand Governments will now explore other options for harmonisation.
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Agreements with International Agencies in Relation to the Regulation of Therapeutic Products, Chemicals, and Gene Technology
Cooperative Arrangements between Australia and Canada on the Subject of Sharing Information on New Industrial Chemicals
International arrangements for sharing information on new industrial chemicals were continued in 2006–07, when a renewed Canada-Australia Bilateral cooperative arrangement was signed by the Department, through the National Industrial Chemicals Notification Assessment Scheme and the Canadian departments of Health and the Environment. Under the arrangement, the scheme can receive environmental/health assessment reports for new chemicals and Free Early Introduction Permits are available for Polymers of Low Concern where they were assessed as Low Concern Polymers in Canada.
Benefits of the arrangement include increased efficiency achieved through greater transparency in new industrial chemical assessments. It can also lead to a possible reduction in animal testing, a reduction in resources needed for new industrial chemicals work in governments and industry, and speed up product introduction for some chemicals.
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Australia-Canada Memorandum of Understanding on Quality Management Systems Certification for Medical Device Manufacturers
Efforts continued in 2006–07 to streamline the export of medical devices between Australia and Canada. Following negotiations with Canada, the Therapeutic Goods Administration signed a Memorandum of Understanding on Quality Management Systems Certification for Medical Device Manufacturers with the Health Products and Food Branch Health Canada on 1 June 2007. The signing was the culmination of work commenced in 2004 and is an important arrangement that will assist industry by enhancing regulatory cooperation between the two regulatory bodies. Upon completion of the Confidence Building Exercise, the Memorandum will allow for the recognition of Quality Management Systems certifications issued by both bodies, and as a result, will prevent duplicate assessments of their quality management systems.
Other International Activity
In 2006–07, the Department, through the Therapeutic Goods Administration, participated in a number of international fora such as the Global Harmonization Task Force on medical devices, various World Health Organization (WHO) committees including the WHO Blood Regulator’s Network, the European Pharmacopoeia Commission, and the International Organization for Standardization. The Department’s participation in such international fora helped ensure Australia aligned its policies, regulatory frameworks and standards with international standards. This avoided unnecessary regulatory duplication, burden and cost on manufacturers of therapeutic goods. It also enabled consumers, patients and practitioners to access therapeutic goods in a timely manner.
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Development and Implementation of the Response to the Operational Review of the Gene Technology Act 2000
The Department provided the Secretariat to the Gene Technology Ministerial Council, which comprises representation from all Australian jurisdictions. The Ministerial Council responded to the recommendations of an independent statutory review of the
Gene Technology Act 2000 and the intergovernmental agreement which underpins the national regulatory system for gene technology.
The review concluded that the regulatory system has worked well over the last five years, and recommended a number of changes intended to improve the operation of the Act at the margin. The Department coordinated the required legislative amendments to the Act and Gene Technology Regulations 2001, which came into effect on 1 July 2007. Implementation of the changes to the legislation will provide an efficient and effective regulatory system for the application of gene technologies. This will ensure that the regulatory burden is commensurate with the risks and is based on scientific assessment of risks undertaken by an independent regulator.
The Department, through the Office of the Gene Technology Regulator, amended application forms and other written information pursuant to the legislative changes. These are accessible at
www.ogtr.gov.au. In addition, training programs delivered by key office staff were conducted in each capital city to advise organisations and researchers that work with genetically modified organisms of the consequential changes to the office’s processes and procedures.
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Implemented Import Regulations for Kava
Kava, also known as
Piper methysticum, has sedation and muscle relaxation effects. Kava has been used mainly in eight communities in Arnhem Land (population less than 200) since 1982 as a substitute for alcohol. The abuse of kava has become an increasingly serious problem in Indigenous communities over recent years with the health effects becoming more severe in communities where kava use is not traditional, and where excessive consumption occurs. Adverse health effects associated with kava abuse range from ocular effects, headache, indigestion, chest pain and general poor health, through to serious skin conditions, liver toxicity and malnutrition.
The Northern Territory Government has had in place regulations governing the sale of kava. However, the Government recently enforced existing legislation to restrict the importation of kava into Australia, subsequently reducing availability. Effective from 25 June 2007, the Department ceased issuing permits for the importation of kava unless it was for medical or scientific purposes. From 26 June 2007, the Australian Customs Service detained all kava imports unless they were for medical or scientific purposes.
Incoming passengers (aged 18 years or over) to Australia will continue to be allowed to import up to two kilograms of kava in their accompanied baggage, in recognition that kava has traditional ceremonial and cultural uses for Pacific Islanders.
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1 Source: Australian Institute of Health and Welfare [2007] Cervical Screening in Australia 2004-2005.