Author: Team

CHANGE IN CANBERRA

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[vc_row][vc_column][vc_column_text]None more so than in health with the resignation of Greg Hunt as Minister and the outstanding issue of reform to PHI via the Private Health Legislation Amendment Bill.

This Bill will set in place the framework to allow for PHI policies to be categorised as gold, silver, bronze or basic.

The Bill may have a significant impact on the medical device industry as it is may reduce patient reimbursement for medical devices or require consumers to upgrade to more expensive policies, depending upon what policy they hold under the new categorisation.  It has and remains a major issue for the medical device industry.

As of this week it had not been passed by the Senate and now the live issue is that it may not pass into law with the prospect of an early election a very, very real possibility.

If an election is called within the next two weeks, then the Bill will die.  It will either have to be revived by a re-elected Liberal Government under a new Health Minister or a new Labor Government with Catherine King as Health Minister will have to pick up the whole issue of PHI reform from scratch.

As Labor has stated their policy in regard to PHI is to cap PHI increases at 2% for two years while the Productivity Commission conducts a root and branch review of the PHI industry.

Election Timing

Up until this week, the smart money was on a May 2019 election, but the chances of a September or October election are now real.

An early election is problematic for Scott Morrison both in terms of logistics and timing.

In terms of timing, there has to be the passage of a minimum of 33 days from the calling of the Federal election and election day itself.

If an election was called this Monday for instance, then the earliest the election could be held is 29th September and that is AFL Grand Final day.

So Federally, the only realistic dates for an early Federal election are 6 Oct, 13 Oct, 20 Oct and maybe 27 October.

In order to avoid an overlap with the Victorian election which will be held on 24th November the latest an election could be called for say 27th October would be on or around 24th September.

So, there is a three-week window from now until approximately the 24th September for Scott Morrison to call an early Federal election.

The new Prime Minister faces a horror scenario for an October election.  It would see him campaigning during the footy finals season, which will no doubt just annoy a lot of people.

It would also see Victorians going to a Federal and State poll within a couple of months of each other, hardly likely to make the new PM popular.

Remember too, back in 2016 Malcolm Turnbull personally contributed $1.5m to the Liberal Party to help fund the Liberals campaign – well that won’t be happening again.

All in all, the new PM faces the worst of all worlds in regard to an October election.  But he may have no choice but to go to the polls, so the people can sort out the mess that the Government has created.[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_zigzag][/vc_column][/vc_row][vc_row][vc_column width=”1/4″][vc_single_image image=”1915″ img_size=”full”][/vc_column][vc_column width=”3/4″][vc_column_text]

ABOUT THE AUTHOR

Jody Fassina is the Managing Director of Insight Strategy and has been an strategic adviser to MedTech and pharmaceutical stakeholders.[/vc_column_text][/vc_column][/vc_row]

PULSELINE FACT CHECKS THE ABC CLAIMS

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[vc_row][vc_column][vc_column_text]It’s incorrect to say the regulatory environment in Australia has not changed. In 2014 an extensive review of Medicines and Medical Devices Regulation was undertaken by a panel of three eminent experts that included Emeritus Professor Lloyd Sansom AO.

That Panel made 58 recommendations, with the Government supporting 56 of them. Since then a series of legislative reforms has been put in place to regulate medical devices.

The TGA is regarded as one of the most thorough of any agency around the world and has undertaken extensive reforms of medical devices. Its rigorous premarket requirements for medical devices are aligned to international best practice.

ABC has now carried several biased and misleading articles questioning the value of the medical technology industry to the Australian healthcare system.

Global advances in medical technology over the past 20 years have resulted in a 56% reduction in hospital stays, 25% decline in disability rates, 16% decline in annual mortality and increased life expectancy of approximately 3.2 years.

The story failed to recognise doctors and other healthcare professionals are the primary users of medical technology and the industry provides physicians the tools they need to improve patient care. To ensure better outcomes for patients, surgeons need training and familiarity with medical devices.

The rapid innovation which is the hallmark of the medical technology industry – and which serves to benefit patients – would not be possible without the close collaboration between physicians and companies.

Indeed, some of the most significant medical technology breakthroughs in the last 50 years have originated with physicians who saw an unmet patient need or way to improve an existing procedure and brought their idea to a manufacturer to refine and produce for a wide patient audience.

Unlike pharmaceuticals, medical devices are implanted by surgeons and need to last for years, the more familiar a doctor is with a device, the better the outcome for the patient. That’s why medical technology companies provide extensive education and training (or retraining) of surgeons.

It’s also why technicians often support surgeons in the procession of instruments used ensuring they are all in place, and with their order of use. Technicians are highly trained specialists with intimate knowledge of the medical device being implanted and the tools used during that surgery.

PulseLine will continue to take a close look at the reporting of other media outlets and will call out errors, misrepresentation and bias. [/vc_column_text][/vc_column][/vc_row]

KING TAKES RECORD TO SENATE

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[vc_row][vc_column][vc_column_text]Last week the Government announced it will amend the 2012 legislation, introduced by the then Labor Government, to ensure that if users wish to cancel their record they will be able to do so permanently, with their record deleted from the system forever.

These amendments come following concerns raised by several stakeholders since the announcement of the opt-out period, including the Australian Medical Association and the Royal College of General Practitioners who both requested the Government extend the opt-out period to give Australians more time to consider their options.

Uncertainty around the security and privacy of Australians’ having their health data being stored on a central government system had dogged the Government, as more than 20,000 Australians opted-out of the system in the first day.

The Government has attempted to reassure the public their data would be secure using the My Health Record, citing the success of the 6 year pilot program, which the Government says remained secure. The Health Minister also confirmed that the amendments to the legislation will ensure no records can be released to police or Government agencies, for any purpose, without a court order.

The Government has said its amendments will help strengthen the legislation to match the existing Australian Digital Health Agency policy. However, the Opposition remains unconvinced.

Shadow Health Minister, Catherine King MP, says the Opposition remains deeply concerned about the way the Government has handled the My Health Record opt-out period, claiming it has severely undermined the public trust in the reform.

Ms King believes that while the Government has agreed to a number of changes demanded by the Opposition and doctors’ groups, including an extension of the opt-out period and a new public information campaign, more needs to be done.

The Opposition will seek crossbench support to refer the rollout to the Senate Finance and Public Administration References Committee, which could also inquire into the census failure and the sale of Medicare numbers on the darkweb.

Ms King said the inquiry will examine the Government’s decision to shift from an opt-in system to an out-out system and whether it adequately prepared for this fundamental change from Labor’s system.

“[The inquiry] will examine a range of privacy and security concerns, including the adequacy of the system’s log-in procedures and default settings. It will also consider issues raised in the public domain around domestic violence and workers’ compensation,” Ms King said.

“Labor remains of the view the Government should suspend the My Health Record rollout until this mess can be cleaned up.”

It is expected that the committee will be asked to report back on its findings before the end of the opt-out period in mid-November.[/vc_column_text][/vc_column][/vc_row]

$80,000 CALL FOR AUSTRALIA’S PATHBREAKING HEALTHCARE INNOVATORS

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[vc_row][vc_column][vc_column_text]Now in its fifth year, MedTech’s Got Talent, an initiative of the Actuator, is on the search to identify and refine high-potential MedTech concepts from aspiring next-generation early stage entrepreneurs and innovators associated with Australia’s world-class universities, hospitals and research institutes.

Successful applicants will receive support to develop an investable start-up pitch, developing a go-to-market strategy, and initiating commercial activities. Participants will vie for over $80,000 in cash prizes plus critical support, such as mentoring from Australia’s leading commercialisation and technology experts.

Founder and CEO of the Actuator, Dr Buzz Palmer, is keen to emphasise the importance of the MedTech’s Got Talent competition in stimulating an entrepreneurial culture within the Australian MedTech community.

“The reason why we have been running the MedTech’s Got Talent competition for the past five years is to support start-ups, researchers, healthcare professionals or anyone who has an interest in MedTech to share their ideas, take risks and embrace failure. It is only through this entrepreneurial mindset that our innovation ecosystem grows, and great MedTech ideas become a reality,” Dr Palmer said.

Victoria’s Minister for Innovation and the Digital Economy, Philip Dalidakis, believes its important to highlight the role of the Actuator in enabling the commercialisation of new MedTech ventures.

“We’re one of the world’s largest life science clusters and possess world leader research and advanced manufacturing capabilities. Victoria’s potential to create innovative healthcare solutions is among the world’s best and the Victorian Government is proud to support local start-ups and help them achieve their full potential through the MedTech Actuator,” Mr Dalidakis said.

Applications for the 2018 National round close on the 27th of September. For full program details, eligibility and to apply, visit www.medtechchallenge.com.[/vc_column_text][/vc_column][/vc_row]

DESPITE NIB POSTING $184 MILLION PROFIT ANOTHER 57000 AUSTRALIANS DROP PHI COVER

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[vc_row][vc_column][vc_column_text]The quarterly Private Health Insurance figures show another 57,512 insured persons dropped out, with the largest decrease in coverage during the quarter coming from people aged 20 and 24, the very group that needs to remain in the system to reduce the risk rating.

Despite this private health insurers collected $23.9 billion in premiums, paid $20.5 billion in benefits and reported net profits after tax of $1.37 billion, 15 per cent higher than two years ago.

NIB chief executive Mark Fitzgibbon said that the “benign” claims environment had resulted in NIB upgrading its full-year profit forecast by 14 per cent. Although private health insurers provided firm commitments that cuts to the Prostheses List benefits would be fully passed on to consumers, NIB’s profit upgrade shows the end result will be a surge in NIB’s profits.

Public frustration with insurers increasing annual premiums by more than double the rate of wage growth comes as a Parliamentary Senate inquiry recommended passing legislation that includes key components of the Minister for Health, Greg Hunt MP’s, wide ranging package of reforms to make private health insurance simpler and more affordable for Australians.

Stakeholders are increasingly voicing concerns around certain components of the reform package. The ambitious timeline for introducing Basic, Bronze, Silver and Gold policies from 1 April 2019 is increasingly problematic.

Spinal surgeon, Dr Matthew Scott-Young, says his field will be one of the hardest-hit by the reforms. Some surgical interventions that consumers commonly rely on such as spinal fusion, would require the highest and presumably most expensive level of cover despite many of these procedures being available today to people holding lower levels of cover.

“People like the reliability and certainty with their insurance and these changes, while in good faith, don’t deliver that,” Dr Scott-Young said.

“The analogy would be that a lady who was pregnant came into hospital to deliver their child through natural birth, but unfortunately there was a complication such that a caesarean section had to be done and they found out they weren’t covered.”

One supporter of the government’s private health insurance reforms has been the Medical Technology Association of Australia (MTAA), but they too have raised concerns around the product categorisation issue of gold, silver, bronze and basic policies. The MTAA CEO, Ian Burgess, believes the proposed categorisations would negatively impact on consumers, leaving them worse off compared to the current system.

“We have expressed to the Health Minister our concerns that insurers will choose to no longer offer these services, like spinal fusion, on the lower categories. This could lead to a further retraction in the number of people with private health insurance or a reduction in the number of people covered by effective health insurance that properly covers them for their needs. In either case there is a risk that further burden would be placed upon public health services for elective surgery and increased waiting lists for common procedures such as joint replacements,” Mr Burgess, said.

“We are discussing with Minister Hunt the need to protect consumers to ensure they are not required to pay higher premiums just to maintain existing levels of insurance coverage as a result of the product categorisations.”[/vc_column_text][/vc_column][/vc_row]

Baxter Compounding Pharmacy

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[vc_row][vc_column][vc_column_text]Baxter operates eight TGA / Medsafe accredited compounding centres that employ over 450 pharmacists, technicians and operations staff. All of Baxter’s Pharmacy Services staff are trained to the same exacting set of standards and procedures and consistently achieve industry-leading quality and service levels.[/vc_column_text][/vc_column][/vc_row]

$9.85 MILLION TO GET MEDICAL DEVICES TO MARKET

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[vc_row][vc_column][vc_column_text]New South Wales Minister for Health and Medical Research, Brad Hazzard, announced the recipients of the 2018 NSW Medical Devices (MDF) which invests in the development and commercialisation of medical devices and related technologies.

“Since the Medial Devices Fund began in 2013, the NSW Government has awarded more than $50 million in grants to 31 technologies,” Mr Hazzard said.

“We are committed to supporting innovators in the MedTech industry in getting their brilliant ideas off the ground and ultimately saving millions of lives around the world.”

MDF past recipients have now raised more than $456 million in funding, treated more than 180,000 patients and all have quadrupled their staff in the process.

Office for Health and Medical Research Executive Director, Dr Antonio Penna, said Sydney-based Ellen Medical Devices has received $2.2 million to develop a portable, solar-powered dialysis machine, costing just $1,000 to build and $5 a day to run.

“Dialysis can cost up to $100,000 per patient each year in Australia and up to seven million people die annually in developing countries because it is too expensive,” Dr Penna said.

Among other recipients is Wollongong-based company Eudaemon Technologies, which has received $1 million to develop a condom made from an innovative material called hydrogel which is non-allergenic.

It is expected the product will enhance sexual experience, making it more popular and therefore potentially save healthcare agencies millions of dollars worldwide by reducing the incidence of sexually transmitted diseases.

THE 2018 NSW MEDICAL DEVICES FUND WINNERS ARE:

  • Kico Knee Innovation Company Pty Ltd ($2.5 million): Customised total knee replacement technology platform. The platform has software and hardware components that provide orthopaedic surgeons and patients with dynamic, functional and patient-specific solutions. It is primarily aimed at Australian and US markets.
  • Ellen Medical Devices Pty Ltd ($2.2 million): An affordable dialysis system which will provide access to life-saving treatment to millions of kidney patients around the world. Dialysis is a safe and effective treatment for kidney failure, but expensive at $50,000-$100,000 per patient per annum in Australia.
  • Cenof ex Innovations Pty Ltd ($1.5 million): A device to improve treatment of side effects of the incurable chronic and painful disease, Lymphoedema. It is capable of activity moving lymphatic fluid while incorporating a patient’s need for comfort, portability, and ease. The disease can also lead to dangerous infections, restricted movement and depression.
  • iFix Medical Pty Ltd ($1.15 million): The iFix system can deliver a 3D-printed structure directly onto the eye to seal wounds in the treatment of corneal ulceration, better preventing infection, relieving pain and accelerating healing. The condition is extremely painful and accounts for 55,000 hospital presentation each year in Australia.
  • Eudaemon Technologies Pty Ltd ($1 million): A next-generation, non-allergenic condom made from hydrogels that act like latex rubber but with enhanced feel and self-lubrication and without odours or tastes. Although condoms can prevent both pregnancy and STIs they are often avoided due to the stigma of reduced sensation.
  • Trimph Technology Pty Ltd ($1 million): TrimphDent, a ready-to-use, injectable scaffold that is applied immediately after tooth extraction and has been shown to preserve the socket. Tooth extraction is an inherently traumatic procedure that damages the underlying tissues and leads to inevitable jaw bone shrinkage.
  • Indee Pty Ltd ($500,000): This inexpensive mechanical process to make gene-modified cells will solve the development and manufacturing issues associated with current gene therapies and ensure greater access to treatment. The impact of gene-modified cell therapies will be similar to that of antibiotics seen during the last century. In the near term, their therapies will provide cures for most cancers.

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MY HEALTH RECORD OPT-OUT PERIOD EXTENDED

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[vc_row][vc_column][vc_column_text]This was a key request from the Australian Medical Association and the Royal College of General Practitioners and gives Australians more time to consider their options as we strengthen the 2012 My Health Record legislation.

The Government will amend the 2012 legislation to ensure if someone wishes to cancel their record they will be able to do so permanently, with their record deleted from the system forever.

This means any Australian will be able to opt-out of the system permanently, at any time in the future, with their record deleted for good.

The government has said it will also strengthen the legislation to match the existing Australian Digital Health Agency policy.

This policy requires a court order to release any My Health Record information without consent.

The amendment will ensure no record can be released to police or government agencies, for any purpose, without a court order.

The Australian Digital Health Agency’s policy is clear and categorical – no documents have been released in more than six years and no documents will be released without a court order. This will be enshrined in legislation.

As the Australian Digital Health Agency has already stated, contrary to incorrect claims made by unions this week, under the Healthcare Identifiers Act 2010, specifically subsection 14(2), healthcare providers cannot be authorised to collect, use or disclose a healthcare identifier, and as a consequence access a patient’s My Health Record, for employment and insurance purposes.

Under the Act it is expressly prohibited and using or disclosing a healthcare identifier without authority is an offence and subject to severe penalties, including two years in jail and a fine of $126,000.

Last week in Alice Springs all health ministers unanimously reaffirmed their support for My Health Record, the national opt-out approach and our steps to strengthen the legislation.

Minister for Health Greg Hunt said he welcomed the bi-partisan support from both Labor and Liberal state governments for this important health reform.

As health ministers noted at the meeting, the expert clinical advice is that My Health Record will deliver better health care for patients.

The Government will also work with medical leaders on additional communications to the public about the benefits and purpose of the My Health Record, so they can make an informed choice.[/vc_column_text][/vc_column][/vc_row]

DIGITAL HEALTH A $200 BILLION INDUSTRY BY 2020

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[vc_row][vc_column][vc_column_text]Software and technologies that assist in diagnosis, treatment options, storing and sharing health records, and managing workflow can enable more efficient clinical practice. The proliferation of digital health tools, including mobile health apps and wearable sensors, holds great promise for improving human health.

By some accounts there are now over 318,000 health apps available on the top app stores worldwide, nearly double the number of apps available in 2015 – with more than 200 apps being added each day.

In today’s environment, apps can be created by anyone with a good idea and some programming skills.

When barriers to entry are low, how do you differentiate yourself? But more importantly how does the industry and regulators ensure the quality of the technology can be directly linked to clinical evidence sufficient to demonstrate an appropriate level of safety and performance when used for the intended purpose.

That’s why this week the TGA recognised that to continue providing a clear regulatory environment for medical devices in Australia, it is essential that it engage with the medical devices ecosystem during the development of new regulatory recommendations and guidelines. The TGA has commenced consultation, through CSIRO Futures, in the areas of Software as a Medical Device (SaMD), and Cyber Security for Medical Devices (CSfMD).

As with all other medical devices, the regulation of medical device software and mobile medical apps that are medical devices is risk-based. This means that the level of scrutiny and oversight by the TGA applied to a product will vary according to the level of risk that the product represents to the patient or healthcare professional using it. The potential risks arising from medical devices can be minor, or very significant indeed, depending on the nature of the device and its intended purpose.

PulseLine will be taking a keen interest in this project as it evolves. If you want to get involved contact the team using the link below, before close of business on the 20th of August 2018.

CSIRO project team member Dr Jill Freyne.[/vc_column_text][/vc_column][/vc_row]