Category: Community

Medical Technology Industry’s Commitment To Ethical Practice

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[vc_row][vc_column][vc_column_text]The Medical Technology Association of Australia’s (MTAA) Code of Practice (the Code) is mandatory for member companies and sets high standards for ethical interactions with healthcare providers.

The Code ensures that decision-making on selection and use of products by doctors, or hospital purchasing departments, is based solely on the quality and suitability of the product, not on inducements (perceived or otherwise) paid to the doctor or other decision-maker.

While the Code is not legislated, it does serve as an industry best practice guide for all medical technology companies to follow, and the MTAA takes seriously any alleged breaches of its Code.

Breaches of the Code may be referred, by the Code Authority, to an independent complaints committee for investigation, and may result in the imposition of financial penalties.

There is very high compliance with MTAA’s Code amongst members. However, device companies who are not MTAA members do not have such a Code. MTAA calls for the implementation of a harmonised industry code of practice which all device manufacturers and suppliers are required to adhere to by law or regulation. The MTAA Code of Practice would be an appropriate basis for such a harmonised code.

This is the 11th edition of the MTAA Code of Practice. Updates include:

  • A requirement for Code training to be completed by new employees within three months of commencing employment
  • Amendments to ensure the complaints process is simplified and that any party involved in a complaint has a clear understanding of the process and what is required of them.
  • Amendments to ensure alignment with the requirements of the recent Commonwealth Whistle-blower legislation.

 

MTAA is firmly committed to the high-standards of integrity and ethical behaviour of the industry as it continues to assist Australians to lead healthier and more productive lives through timely access to innovative and safe medical technology.

The Code is available on the MTAA website.[/vc_column_text][/vc_column][/vc_row]

BioMedTech Horizons: Round 3 Applications Are Now Open

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[vc_row][vc_column][vc_column_text]Expressions of interest are now open for the third tranche of funding, with grants of up to $1 million available for medical device projects targeting innovative solutions to address unmet clinical needs in three key focus areas:

Digitally enabled medical devices in mobile health, health information technology, wearable devices, telehealth and telemedicine, and digitally enabled personalised medicine Digitally enabled implantable medical devices addressing unmet needs in any therapeutic area General medical devices in the areas of regenerative medicine, women’s health, cardiovascular, orthopaedics, neuroscience, general surgery and oncology.

This funding, BMTH3.0, is delivered via the Medical Research Future Fund (MRFF), and administered by MTPConnect, the Medical Technology and Pharmaceutical Industry Growth Centre.

Investments from the program are focused on funding proof-of-concept to commercial development of biomedical and medical technologies (biomedtech).

The funding provided for the BioMedTEch Horizons initiative is thanks to an Agreement signed between MTAA and the Commonwealth Government.

For more information and to apply, visit https://www.mtpconnect.org.au/biomedtechhorizons.[/vc_column_text][/vc_column][/vc_row]

NEW REPORT HIGHLIGHTS VALUE OF ACCESSING CATARACT TREATMENT THROUGH THE PROSTHESES LIST

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Cataracts and glaucoma impose a substantial burden on hundreds of thousands of Australians through reduced vision, leading to lower quality of life, greater health system expenditure, productivity losses, informal care costs, and reliance on aids and modifications.

“Our report found that access to intraocular lenses through the Prostheses List saved government, patients and society $371m in 2017-2018,” said Lynne Pezzullo, Partner at Deloitte Access Economics, today.

“If all cataract surgery was completed in the private sector, additional savings to Government would be $162m. For each additional surgery that shifted to the private sector, individuals would save $836 and Government would save $1,885 per procedure,” Ms Pezzullo said.

Privately insured patients have access to a broad choice of medical devices through the PL, which is a key component of the value proposition of private health insurance.

“Timely access to cost effective private ophthalmic surgeries through the Prostheses List reduces the economic burden of ophthalmic conditions and gives patients greater choice of ophthalmic devices,” said Ian Burgess, MTAA CEO, today.

“The devices industry was the sole contributor to lower private health insurance premium increases both in 2017 and in 2018. MTAA’s Agreement with the Government is on track to exceed $1.1 billion in expected savings, however, further cuts to the Prostheses List could erode these benefits.

“Further cuts to incentives for private ophthalmic treatment could drive more patients into the public system, putting greater pressure on an already over-burdened system,” Mr Burgess said.

A reduction in revenue may also reduce the ability of niche technology providers to bring new products to the market.

“The medical technology industry believes access to a full range of medical technology is one of the key benefits of having private health insurance and we’re committed to helping ensure all Australians lead healthier and more productive lives,” Mr Burgess concluded.

$8 million for ground-breaking clinical trials

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[vc_row][vc_column][vc_column_text]Five Australian-led trials will receive funding from the Government’s Medical Research Future Fund International Clinical Trial Collaborations program.

Researchers at the University of Western Australia will receive $1.8 million to investigate the best approach for treating severe narrowing of the aortic heart valve (aortic stenosis), which is a very common condition.

This large clinical trial will test if earlier valve replacement will improve outcomes for patients.

Macquarie University has received $3.1 million to investigate reducing the risk of dementia by protecting brain health through lifestyle changes.

The George Institute for Global Health will receive $902,000 to evaluate the best treatments for aneurysmal subarachnoid haemorrhage caused by a burst artery in the brain.

In people aged between 40 and 60 years with this condition, nearly half will die and a third will suffer permanent disability. The clinical trial will help doctors better manage patients with this condition.

The University of Newcastle will receive $782,000 to trial the use a new type of wound dressing on patients to reduce infections following emergency abdominal surgery.

The Murdoch Children’s Research Institute will receive $1.4 million to investigate the best ways to support fragile lungs in preterm babies, which are prone to collapse and cause injury from the first time they breathe.

While positive end-expiratory pressure (PEEP) at birth is essential to support the preterm lung, this project will conduct the first large clinical trial of PEEP strategies in preterm infants.

This clinical trial will provide important guidance to clinicians across all health care settings worldwide.

Each project will run at least one clinical trial site in Australia with Australian patients, while collaborating with international researchers or trial teams.

The International Clinical Trial Collaborations program supports Australian researchers, to collaborate globally to develop new or novel drug applications, devices and treatments.
The $20 billion Medical Research Future Fund is an endowment to provide a sustainable source of funding for vital medical research.[/vc_column_text][/vc_column][/vc_row]

TGA publishes updated Enforceable Undertaking guidelines

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Under section 42YL of the Therapeutic Goods Act 1989 (the Act), the Secretary of the Department of Health can accept an offer of an enforceable undertaking. An enforceable undertaking is relatively quick compliance solution. It may include encouraging entities (individuals or companies) to improve their compliance arrangements or restrict the activities they can undertake. This can help entities meet their obligations under the Act and other regulations into the future, which in turn helps protect consumers and public health.

The TGA regards the enforceable undertaking as an important compliance tool in situations where there is evidence of a breach of the Act or regulations, but where it may not be in the public interest to take civil or criminal compliance action. Generally, enforceable undertakings are not used in cases involving deliberate misconduct, fraud, or conduct involving a high level of recklessness.

For an individual or company in potential breach of the Act or regulations, entering into an enforceable undertaking can be a cost-effective alternative to criminal or civil compliance action.

A Conversation with AlphaBeta’s Andrew Charlton

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Andrew has senior experience in business, government and international institutions. After commencing his career with the Boston Consulting Group (BCG), he received a Doctorate and Masters in Economics from the University of Oxford, where he studied as a Rhodes Scholar. From 2008-2010, through the period of the global financial crisis, he served as senior economic advisor to the Prime Minister of Australia and Australia’s senior government official to the G20 economic summits. He was the prime minister’s representative to conferences of the United Nations Framework Convention on Climate Change (UNFCCC) and the Major Economies Forum on Energy and Climate (MEF). From 2010-2014 he worked for Australian conglomerate Wesfarmers, including two years in corporate strategy (M&A and major group projects) and two years in operational roles (divisional Chief Financial Officer and General Manager).

Andrew’s academic research covering international economics, trade and development has been published in leading international journals including the American Economic Review, World Trade Review and World Economy. He is the author of two books, Ozonomics (2007) and Fair Trade for All (2005), co-written with Nobel laureate Joseph Stiglitz. In 2011 he was named a Young Global Leader by the World Economic Forum.