Australia: Health Related Critical Judgments, Legislation, Press Releases and News Items

Health Alert 1 November 2010
Last Updated: 1 November 2010
Article by Kerry Hogan-Ross

Health Alert is a summary of the critical judgments, legislation, press releases and news items which have come to our attention each week. Many of the summaries will contain a hyperlink.

If an item is of special interest, we may insert commentary into the body of Health Alert.  However in general, Health Alert is a quick and effective means of ensuring that you are aware of significant recent changes with little or no commentary from ourselves.

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Australia. Administrative Appeals Tribunal

Ego Pharmaceuticals Pty Ltd and Minister for Health and Ageing [2010] AATA 825 (26 October 2010)

Ego Pharmaceuticals Pty Ltd (Ego) applied for a review of a decision of the delegate of the Minister for Health and Aging to refuse applications made pursuant to the Therapeutic Goods Act 1989 (Cth) for the registration of Zatamil ointment, lotion and hydrogel.

Pharmaceutical products can only be marketed if they are registered in the Australian Register of Therapeutic Goods. Registration will be approved when quality, safety and efficacy have been satisfactorily established. In the case of pharmaceuticals containing the same active ingredient as products already registered, the requirements of the system may be less stringent than with new products. The new product is known as a ''generic''.

Ego sought approval to market such a generic, for use topically to treat dermatitis and other skin conditions. The generic is to be called Zatamil. The established product is called Elocon or Novascone. Although the active ingredient in products is identical, the bases of the ointment, lotion and hydrogel in which they are carried, are not. The question before the Tribunal was whether the testing undertaken by Ego sufficiently demonstrated equivalence between the two products to satisfactorily establish the quality, safety and efficacy of Zatamil for the purposes for which it is to be used.

The Tribunal was not satisfied that the evidence before it met the requisite equivalence. While the Tribunal declined to register Zatamil, it saw no reason why the product should not be registered if further tests were performed to achieve equivalence with the established product.

New South Wales. Medical Tribunal

15/10/2010: Martin, Jason

In 2003, the applicant, Jason Martin, became addicted to codeine. Following a hearing before the Impaired Registrants Panel, the applicant agreed to conditions being placed on his registration effective from 4 August 2004. The applicant breached some of these conditions. The Health Care Complaints Commission initiated proceedings before the New South Wales Medical Tribunal in March 2009.

The substance of the complaints was that the applicant had administered a narcotic derivative non-prescription compound analgesic and/or cold medication on 17 occasions between 20 December 2004 and 28 September 2007. The drugs detected were morphine and, on two occasions, pseudoephedrine. It was also alleged that the applicant, who was required to attend for urine testing three times per week, had provided dilute or very dilute samples on 72 occasions between December 2004 and September 2007 which registered the tests invalid.

Before the March 2009 Tribunal, the applicant admitted he had breached the conditions. He attributed his conduct to anxiety and depression. He also said he had a poor attitude caused by negative thought processes and he resented having to conform to the conditions of his registration.

The Tribunal reinstated the applicant's registration after he was de-registered in August 2009, subject to a number of conditions. The Tribunal noted that since the August 2009 hearing the applicant had entered into a regime of drug testing on a consistent basis and the tests had, without exception, been consistent with an absence of drug taking. The Tribunal concluded that these matters suggested a firm resolve on the applicant's part to discharge the proper ethical and professional standards expected of all medical practitioners.

15/10/2010: Woods, Ray

New South Wales

Ng v NSW Health Care Complaints Commission [2010] NSWSC 1220 (22 October 2010)

PHARMACIST – Deregistration – Continuing unfitness – Whether remorseful – Significance of finding of dishonesty – Requirements of procedural fairness – Whether breach of rule in Brown v Dunn - Error of law – Mistake of fact – Whether Supreme Court should hear and determine consequential orders when quashed – Remit to Tribunal for determination.



Federal Financial Relations Amendment (National Health and Hospitals Network) Bill 2010 [Bill Homepage] - Date: 27/10/2010 09:38:51 - Collection: Bills and Legislation - ID: legislation/billhome/r4485 - Source: House of Reps

Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 3) - F2010L02787 - Health - These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to allow reduced assessment fees relating to IVDs where, under specified circumstances, an abridged assessment can be carried out.

Health Insurance (General Medical Services Table) Regulations 2010 - F2010L02791 - Health - These Regulations repeal the Health Insurance (General Medical Services Table) Regulations 2009 and prescribe a new Table for the 12 month period commencing 1 November 2010.

Health Insurance Amendment Regulations 2010 (No. 4) - F2010L02797 - Health - These Regulations amend the Health Insurance Regulations 1975 to implement a 2010-11 Budget measure to recognise Addiction Medicine, Sexual Health Medicine and Sport and Exercise Medicine as medical specialties.

Health Insurance (Diagnostic Imaging Services Table) Regulations 2010 - F2010L02765 - Health - These Regulations repeal the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 and prescribes a new table for the 12 month period commencing 1 November 2010.

Health Insurance (Pathology Services Table) Regulations 2010 - F2010L02766 - Health - These regulations repeal the Health Insurance (Pathology Services Table) Regulations 2009 and prescribes a new table for the 12 month period commencing 1 November 2010.

Health Insurance (Positron Emission Tomography) Facilities Determination 2010 (No. 2) - F2010L02816 - Health - This Determination revokes and replaces the Health Insurance (Positron Emission Tomography) Facilities Determination 2010 to allow for continued eligibility of Medicare benefits for positron emission tomography services.

Therapeutic Goods Amendment Regulations 2010 (No. 4) - F2010L02771 - Health - These Regulations amend the Therapeutic Goods Regulations 1990 to provide for the disposal of unused medical devices, allows for reduction of certain fees applying to in-vitro diagnostic medical devices and provides for other consequential changes.

Health Insurance Amendment Regulations 2010 (No. 2) - F2010L02796 - Health - These Regulations amend the Health Insurance Regulations 1975 to make consequential amendments due to changes to the General Medical Services Table.

Health Insurance Amendment Regulations 2010 (No. 3) -  F2010L02770 - Health - These Regulations amend the Health Insurance Regulations 1975 to specify the pathology and diagnostic imaging services a participating midwife or participating nurse practitioner can request as Medicare eligible services; and a period of validity for referrals to specialists and consultant physicians made by a participating midwife or participating nurse practitioner.

Health Insurance (Home-Based Sleep Studies) Determination 2010 (No. 1) - F2010L02723 - Health - This Determination is to provide retrospective legal authority for annual indexation that was applied from 1 November 2009 to the Medicare Benefits Schedule fee for home-based sleep study which was indexed without a determination to reflect such an increase.

Health Insurance (Home-Based Sleep Studies) Determination 2010 (No. 2) - F2010L02724 - Health - This Determination permits ongoing payment of Medicare benefits for home-based studies ordered and analysed by practitioners qualified in the field of adult sleep medicine.

New South Wales

Health Services Amendment (Local Health Networks) Bill 2010 - Legislative Assembly and received its second reading speech on 21 October 2010.

Assisted Reproductive Technology Act 2007 - Assisted Reproductive Technology Amendment (Infection Control Standards) Regulation 2010 (2010-598) LW 22 October 2010 - commenced on 22 October 2010.

Surrogacy Bill 2010 - private member's Bill, sponsored by John Hatzistergos, was introduced into the Legislative Council and received its second reading speech on 21 October 2010.


Australia. Department of Health & Ageing

Media releases

28 October 2010 - E-Health Conference - Revolutionising Australia's Health Care - The nation's leading health experts, consumer groups and information technology specialists will come together to discuss the technological revolution in the delivery of health care at an e-health conference later this year.

28 October 2010 - National Epidermolysis Bullosa Scheme Helping Those In Need -This week, 26-31 October, is International Epidermolysis Bullosa Awareness Week and an important opportunity to highlight this rare and debilitating genetic disease.

28 October 2010 - Process Commences For The Next 28 GP Super Clinics - Minister for Health and Ageing, Nicola Roxon, announced the start of the process of delivering 28 new GP Super Clinics to local communities around Australia, an extra $233m investment in primary healthcare.

27 October 2010 - Consultation Open on Alcohol–Free Community Sponsorship Fund - As part of its National Binge Drinking Strategy, the Australian Government is seeking input from the community on how to remove links between alcohol and community sporting and cultural activities that young people are involved in.

25 October 2010 - New Eye Surgery 'Blitz' in Central Australia - A six-day intensive eye surgery 'blitz', funded by the Australian Government and coordinated by the Fred Hollows Foundation, has begun at Alice Springs Hospital.

22 October 2010 - $8 Million Boost For Remote And Regional Health Services -People living in rural and remote communities are already benefiting from an innovative program that is boosting health and medical services in communities across the nation.

Health Alert: Recall of food products containing an undeclared therapeutic substance - On 22 October 2010, Food Standards Australia New Zealand (FSANZ) advised that a recall was being conducted for Sumabe Acai Berry Coffee, Moti Angel Coffee and Leptin Weight Loss Chocolate due to the undeclared presence of the therapeutic substance, sibutramine.

Private Health Insurance Circulars

PHI 69/10 - Appointment of the new Prostheses List Advisory Committee

National Carer Strategy - The National Carer Strategy will formally acknowledge the vital role of carers. The strategy will provide a national framework for the development and implementation of policies, programs and services for carers as well as bring together the different reform agendas that impact on carers across governments - 18 October 2010

Australia. Therapeutic Goods Administration

Media releases

Consultation: Improving advertising arrangements for therapeutic goods (added submissions)

TGA legal expenditure (updated)

Australian Public Assessment Report (AusPAR) for prescription medicines (added Agomelatine)

Consumer safety advisory: So Hard for Men tablets, Shaguar tablets and Pulse8 for Women capsules (new)

IVD regulatory framework - TGA eBusiness Services (eBS) training (new)

TGA prescription medicine streamlined submission process Q&A (updated)

TGA-Industry Working Group (IWG), outcomes of meeting, 8 July 2010 (new)

TGA business process reforms - transitional arrangements from 1 November 2010: Training sessions are being held on 26 October, 29 October & 3 November 2010 in Brisbane, Melbourne and Sydney. Register now at ARCS Australia

Drugs designated as orphan drugs (added C1 esterase inhibitor (CINRYZE))

Australian Public Assessment Report (AusPAR) for prescription medicines

Budesonide/ eformoterol fumarate dihydrate

Human Fibrinogen



Export of human blood/tissue and related materials (updated)

Public submissions: Proposed standards and Code of GMP for human blood and blood components, human tissues and human cellular therapies (new)

Public submissions: Proposed standards for haematopoietic progenitor cells intended for use in haematopoietic reconstitution (new)

Dr Rohan Hammett - biographical details (updated)

TGA customer service charter (updated)

Australia and Canada - reciprocal recognition of manufacturers' quality systems (new)

Fact sheet: Operation of the reciprocal arrangement between the Therapeutic Goods Administration (TGA) and Health Canada's Health Products and Food Branch (HPFB) on manufacturers of medical devices (new)

European Medical Device Directive - Essential requirements checklist (updated)

Australian Health Practitioner Regulation Authority

FAQ: Graduating students apply for registration now...

Australia. National Health & Medical Research Council

Cutting the Risk of Healthcare Infections - 28 October 2010 - The Australian Commission on Safety and Quality in Health Care delivered the Australian Guidelines for the Prevention And Control Of Infection In Healthcare to the Minister for Health and Ageing, the Hon Nicola Roxon MP on Tuesday. » View Media Release

National Guidance on Collaborative Maternity Care

Australian Institute of Health & Welfare

Annual report 2009-10 - The AIHW is a major driving force in Australia for national information and statistics on health, housing and community services. The AIHW's outcome, as stated in the 2009-10 Portfolio Budget. Published 27 October 2010.

AIHW Access no. 28: 2010 - Published 26 October 2010.

Australia. National e-Health Transition Authority

Standards Australia issues RFP for the development of technical specifications to underpin the electronic transfer of prescriptions in Australia - 22 October 2010. Standards Australia is seeking proposals from suitably qualified individuals and/or organisations (Respondents) to assist in the development of six draft Australian Technical Specifications (ATSs) to underpin the electronic transfer of prescription and dispensed medication information processes in Australia. - Read more

Australia. Private Health Insurance Ombudsman

28 Oct 2010 - 2009/10 Annual Report READ MORE

Australia. Professional Services Review

PSR Annual Report 2009 – 2010. Copy available Here

Australian Competition & Consumer Commission

ACCC calls for comment on proposed pharmaceutical acquisition - The ACCC today issued a Statement of Issues on the proposed acquisition of Sigma Pharmaceuticals. Issued: 27 October 2010 Release # NR 233/10

Australian Capital Territory. Department of Health

Media releases

ACT Government focussed on keeping GPs in the Territory Katy Gallagher, MLA October 27 2010

Recall of weight loss products (23 October 2010) - Three brands of weight loss product have been recalled by the NSW Food Authority because they contain sibutramine.

New South Wales. Department of Health

Media releases

Minister Praises Hospital Volunteers [28 October 2010]

Parents reminded to keep household poisons out of reach [26 October 2010]

Product recall due to presence of sibutramine [22 October 2010]

NSW Dementia Services Framework 2010-2015 22/09/2010

Key Recommendations on Pandemic (H1N1) 2009 Influenza from the NSW Health Emergency Management Committee 16/09/2010

Northern Territory. Department of Health & Families

Report of the Board of Inquiry into the Child Protection System in the Northern Territory 2010

Queensland. Department of Health

Media releases

Langbroek must come clean on health cuts: Lucas

26/10/2010 Queenslanders encouraged to have their say on Local Hospital Networks

25/10/2010 Abbott's chance to make amends to Queensland

Health Reform Queensland (new site)

South Australia. Department of Health

Media releases

Private country hospital meeting at Parliament - Thursday, 28 October 2010 - Health Minister John Hill has thanked the representatives of the Keith, Moonta and Ardrossan Hospitals for a positive and cordial meeting at Parliament. Read more...

South Australia. Health & Community Services Complaints Commissioner

Ever felt like complaining? CLOSE THE GAP October 2010  - Health and Community Services Complaints Commissioner Aboriginal and Torres Strait Islander Outreach Project Update - HCSCC has produced a pamphlet and poster for Aboriginal and Torres Strait Islander communities. These resources can be ordered FREE (order form). This form can also be used to request an HCSCC speaker about the project. HCSCC provided a summary report about complaints and outreach activities since January 2010 to the Federal Minister for Indigenous Health, the Hon. Warren Snowdon, on 27 October 2010. (summary report – outreach activities). HCSCC will also be meeting with Minister Portolesi, Minister for Aboriginal Affairs and Reconciliation, South Australia, on 24 November 2010.

Tasmania. Department of Health & Human Services

Media releases

North West UTAS Radiation Science Scholarships Launched Today Minister for Health 27 October 2010

Fresh Food Kids Hospital Appeal Minister for Health 25 October 2010

Social Engineering Not Welcome Here Minister for Health 22 October 2010

Royal Hobart Hospital Leading the World Minister for Health 22 October 2010

Agenda for Children and Young People - 27 October 2010

Victoria. Department of Health

NSW recalls weight loss products containing sibutramine - 27 October 2010 - The Chief Health Officer has issued an alert following a product recall by Food Standards Australia and New Zealand.

Hepatitis C  - 25 October 2010 - As an added precaution, the look back undertaken at Croydon Day Surgery to identify hepatitis C cases is being extended to three more facilities.

Victorian Aboriginal Suicide Prevention and Response Action Plan 2010-2015 - October 2010 - The Victorian Aboriginal Suicide Prevention and Response Action Plan 2010 - 2015 (the Action Plan) is the Victorian Government's strategy to prevent and reduce the incidence and impact of Aboriginal suicide and self harm. The Action Plan development was overseen by a working group comprising Victorian central agencies and Aboriginal community and health organisations.

Ambulance Transport of People with a Mental Illness Protocol 2010 - September 2010 (PDF file 878KB)

VICNISS - eBulletin - Please click here for the most recent eBulletin distributed in October.

Media releases







UPDATE ON HEPATITIS C LOOKBACK Published : - 23/10/2010



Western Australia. Department of Health

Media releases

28 October 2010 - WA Health scoops the pool at Water Awards

24 October 2010 - WA Health reaches agreement with LHMU

22 October 2010 - WA Health response to LHMU statement

22 October 2010 - Product being recalled due to presence of sibutramine

28 Oct 2010 Hames New Hedland Health Campus completed on schedule

25 Oct 2010 Hames New $6million upgrade to WA's Telehealth system launched

New Zealand. Medical Council of New Zealand

An external audit of the Medical Council - In April this year, the United Kingdom based Council for Healthcare Regulatory Excellence (CHRE) undertook an audit of the Medical Council's policies and processes.  The CHRE promotes the health and well-being of patients and the public in the regulation of health professionals. It also scrutinises and oversees the work of the nine UK regulatory bodies that set standards for training and conduct of health professionals. The audit has suggested that openness and transparency, together with public engagement are the two main areas for review by the Medical Council. CHRE final report pdf.  - CHRE report - Philip Pigou - TNS Qualitative research with key audiences Doctors and Stakeholders

New Zealand. Medsafe

NZ takes part in 3rd online global operation against illegal and counterfeit medicines

New Zealand. Health & Disability Commissioner

HRRT decision a strong message for rest home operators - 14 October 2010

United Kingdom. Department of Health

Pandemic H1N1 flu

Mortality Monitoring Bulletin (Life expectancy and all-age-all-cause mortality, and mortality from selected causes, overall and inequalities): update to include data for 2009

The Cancer Drugs Fund - a consultation

European Antibiotic Awareness Day

Antibiotic awareness campaign materials 2010

Self Care Awareness Week: 15-21 November 2010

Contracting for support to Local Involvement Networks in 2011-2012: supporting the possible transition to Local HealthWatch

GP Consortia Pathfinder Programme letter from Dame Barbara Hakin

Canada. Health Canada

The Government of Canada and Food and Consumer Products of Canada Launch Major Nutrition Labelling Initiative [2010-10-22]

American Medical Association

AMA Teams With Press Ganey to Help Physicians Get Valid Patient Feedback - AMA Press Release, October 27, 2010 - New electronic tool measures patient satisfaction to enhance care and lower physician costs - Read the AMA Press Release

Canadian Medical Association

10/28/2010 - Investment in health care offers big returns, CMA tells Ottawa

10/25/2010 - World's MDs discuss growing health threats posed by environment

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