MedTech industry welcomes clinical trials harmonisation

[vc_row][vc_column][vc_column_text]“The medical technology industry has long advocated for national harmonisation of clinical trials and welcomes Minister Hunt’s announcement of a one-stop-shop for ethics approval,” said MTAA CEO Ian Burgess.

“Local clinical trials provide Australian patients with early access to innovative medical devices and treatments and place Australia at the forefront of global advancements of medical technology.

“An active medical device clinical trial environment in Australia will provide local expertise to support Australian start-ups and research groups, accelerating their growth and retaining capability and expertise within Australia,” Mr Burgess said.

For Australia to continue to attract the level of clinical trial activity that it has achieved over the past two decades, it is important that strategies are implemented to enhance the clinical trial environment in Australia including:

  • Reliable, predictable, unified and rapid Site Research Governance
  • A single streamlined ethical review for all studies, irrespective of whether they are conducted in private or public setting and irrespective of phase of study
  • Consistent approaches by States and Territories to support the efficient and cost-effective conduct of studies
  • Establishing an Australian Coordinating Body for Clinical Trials would provide an entity that has the mandate and resources to drive the change needed to improve Australia’s global competitiveness in attracting clinical trials.
  • Supportive and efficient regulatory pathway to transition to commercialisation and reimbursement.

“As we emerge from the COVID-19 crisis, it is more important than ever that we do everything we can to ensure the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community, and we welcome this announcement by Minister Hunt,” Mr Burgess concluded.[/vc_column_text][/vc_column][/vc_row]

PRIVATE HEALTH INSURERS BACKFLIP ON COVID-19 REFUND

[vc_row][vc_column][vc_column_text]Following the announcement of elective surgery bans earlier this year, the insurers made a commitment to ensure they weren’t unduly profiting from the crisis, with PHA CEO Rachel David quoted in the Australian Financial Review on April 8 as saying “if members are getting less for their money – we will address it”.

Fast forward two months, and NIB CEO Mark Fitzgibbon has said that any premium relief looks unlikely, due to the crisis peaking earlier than expected.

“Reduced hospital and ancillary activity did occur in April and into May but quickly recovered and in recent weeks we’ve seen claiming return to normal levels,” said Mr Fitzgibbon this week.

Health workers and industry players across the country, from frontline workers, to researchers and manufacturers have pulled out all the stops in recent months to help fight COVID-19.

“The entire healthcare system has pulled together in an unprecedented effort to support the Australian community through the pandemic, under the strain of enormous cost pressures,” said Ian Burgess, Medical Technology of Australia (MTAA) CEO.

“A significant number of MedTech companies have suffered reductions in revenue of up to 90% as a result of the elective surgery ban.

“This is further compounded by an increase of freight costs of up to 500% and a fall in the Aussie dollar.

“It’s time for the private health insurers to do their bit, rather than just pocketing profits off the back of a global health and economic crisis,” Mr Burgess said.[/vc_column_text][/vc_column][/vc_row]

MedTech crucial to COVID-19 response despite significant hit to industry: new report

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The reports, available here, reveal the true impact of COVID-19 on the MedTech, biotechnology and pharmaceutical sector, an impact felt not only by local SMEs and large multinational companies, but also across the research sector, industry associations and startups.

“The impacts of COVID-19 will be felt across the MedTech industry for many years to come,” said Ian Burgess, MTAA CEO, today.

“The industry is facing significant challenges, including exponential increases in freight costs, the Aussie dollar and the ongoing impacts of the elective surgery pause.

“Despite the challenges posed by COVID-19, we have seen MedTech companies come together in an unprecedented effort to support the Government’s response,” Mr Burgess said.

Through an historical collaboration with the Morrison Government, the MedTech industry successfully secured supplies of essential medical equipment, not only through the global supply chain but through a number of innovative local partnerships that were able to ramp up Australian manufacturing in a remarkably short period of time.

“The MedTech industry has been instrumental in securing essential supplies of ventilators, test kits and PPE on behalf of the Australian Government,” Mr Burgess said.

In addition to sourcing supplies of equipment through the supply chain, in what is being compared to a wartime effort, a consortium of companies was brought together to build a locally produced ventilator, in an unprecedented collaboration involving government, clinicians and manufacturers, many of whom would ordinarily be competitors.

“The efforts undertaken so far represent a significant change in our contemporary understanding of our domestic manufacturing capacity and demonstrate an untapped potential for more homegrown medtech, a potential we may never have realised without the unprecedented threat of a global pandemic,” Mr Burgess said.

“The tangible outcomes of what is coming to be known as the ‘Australia Model’ of government and industry collaboration have demonstrated the role that the MedTech can play in pandemic planning and what can be achieved when government and industry come together in a genuinely cooperative effort.”

“As an industry, we look forward to what we can continue to achieve together in order to strengthen not only Australia’s preparedness for future pandemics, but our healthcare system as a whole,” Mr Burgess concluded.

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People In MedTech – Nicki Walsh

[vc_row][vc_column][vc_column_text]Since starting at Tunstall, Nicki has been successful in achieving gender balance across all levels of the organisation. Her career background has not in fact been medical. Before joining Tunstall, Nicki worked across oil & gas, legal as well as aged care and child care sectors.

Today Nicki’s role as HR Director includes compliance, recognising the impact staff make to the organisation and actively supporting staff and interns within a family friendly and flexible culture.

Tunstall supplies medical emergency alarms and monitoring (Connected Care) and telehealth care products. Nicki tells Pulseline, Tunstall staff have high levels of work satisfaction in supplying medical products that help people live independent lives.[/vc_column_text][/vc_column][/vc_row]

Medical devices industry COVID-19 update

[vc_row][vc_column][vc_column_text]As a member of the Coronavirus Industry Roundtable which is meeting regularly to discuss and address supply chain issues, MTAA has been asked by the Federal Government to lead the industry effort to coordinate the supply of essential medical equipment.

MTAA is coordinating with medical equipment suppliers and manufacturers, including non-members of MTAA, and other relevant industry associations to identify sources of supply and also to provide advice to Government regarding any constraints or obstacles to securing and maintaining supply. This includes identifying current stock, likely quantities that can be obtained through existing supply channels, new sources of supply and potential quantities, and opportunities to increase domestic manufacturing.

These groups will all be focused on providing the Federal Government with advice around supply chain and logistics issues, as well as working directly with state governments to gauge supply and the potential for shortages.

As part of maintaining the supply chain, MTAA is working directly with individual state governments to ensure that medical device services, including technical support and training, are able to continue to operate.

We are also working to ensure that vital technical support services, including service/maintenance/repairs and intraoperative technical support, can still be provided by technicians during medical procedures.

“We are incredibly grateful to the many medical technology companies dedicating significant resources to the effort at a time when their own companies are under an extreme amount of stress,” said Ian Burgess, MTAA CEO.

“The medical devices industry is 100% focused on helping to ensure the continued supply and distribution of vital medical supplies and maintaining Australia’s healthcare system,” Mr Burgess said.

TGA UPDATE

The medical technology industry has also been working closely with the TGA to enable faster access to life-saving medical equipment. A number of exemptions and fast-tracking processes have now been put in place:

  • On 22 March 2020, an exemption was enacted to enable faster access to PPE. This will facilitate necessary access to certain kinds of medical devices that are used for the prevention, monitoring, treatment or alleviation of COVID-19. (In practice, disposable face masks, disposable gloves, disposable gowns, and protective eye wear in the form of goggles, glasses or visors, which are designed to be worn by individuals to prevent the transmission of organisms.)
  • The TGA is currently undertaking an expedited assessment process based on the information and performance data currently available at the time of application for inclusion on the ARTG. All COVID-19 tests that are included on the ARTG based on this expedited assessment process are subject to additional non-standard conditions, which makes it easier for the TGA to perform additional post market assessments as experience and knowledge around COVID-19 diagnostic testing grows. The conditions require that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of approval.

ACCC INTERIM AUTHORISATION TO SHARE INFORMATION

The ACCC has granted interim authorisation to MTAA to allow its members and other groups, such as suppliers or distributors of medical equipment, to share information between each other, co-ordinate orders and supply requests, prioritise requests, and jointly tender to supply COVID-19 medical equipment.

The interim authorisation will allow MTAA members and others to coordinate the manufacture and supply of equipment, and exchange information so that potential supply shortages can be addressed more quickly.

It will also allow industry to keep Federal Government, State and Territory Governments and relevant health agencies up to date on supply issues.[/vc_column_text][/vc_column][/vc_row]

ECONOMIC STIMULUS PACKAGE

[vc_row][vc_column][vc_column_text]The targeted stimulus package is focused on keeping Australians in jobs and helping small and medium sized businesses to stay in business.

The package has four parts:

  • Supporting business investment
  • Providing cash flow assistance to help small and medium sized business to stay in business and keep their employees in jobs
  • Targeted support for the most severely affected sectors, regions and communities;
  • Household stimulus payments that will benefit the wider economy

The measures are all temporary, targeted and proportionate to the challenge we face.  The Government is hoping the actions will ensure it’s response to the immediate challenges Australia faces and help Australia bounce back stronger on the other side, without undermining the structural integrity of the Budget.

Prime Minister Scott Morrison said as part of the plan up to 6.5 million individuals and 3.5 million businesses would be directly supported by the package.

“Just as we have acted decisively to protect the health of the Australian people, based on the best evidence and medical advice, our support package responds to the economic challenges presented by this pandemic in a timely, proportionate and targeted way,” the Prime Minister said.

“Our plan will back Australian households with a stimulus payment to boost growth, bolster domestic confidence and consumption, reduce cash flow pressures for businesses and support new investments to lift productivity.

“Australia is not immune to the global coronavirus challenge but we have already taken steps to prepare for this looming international economic crisis.

“We’ve balanced the budget and managed our economy so we can now use this to protect the health, wellbeing and livelihoods of Australians.

“Our targeted stimulus package will focus on keeping Australians in jobs and keeping businesses in business so we can bounce back strongly.

“The economy needs temporary help right now to bounce back better so the livelihoods of all Australians are protected.”

Treasurer Josh Frydenberg said Australia is approaching the economic challenge from the Coronavirus from a position of strength with IMF and the OECD both forecasting Australia to grow faster than comparable countries including the UK, Canada, Japan, Germany and France.

“Our plan keeps businesses operating, supports jobs and provides a stimulus to households,” the Treasurer said.

“The Government has worked hard over the last six and a half years to return the budget to balance so we have the flexibility to respond to the serious economic challenges posed by the Coronavirus.”

“Given Australia’s strong economic and fiscal position, the international credit rating agency Standard and Poor’s indicated that temporary stimulus would be “unlikely to strain Australia’s creditworthiness.

“In our response, we have been very careful not to repeat the mistakes of previous stimulus programs and not undermine the structural integrity of the budget.

“Today’s announcement will provide the support businesses need to stay in business and keep Australians in a job.

“By acting decisively this package will put Australia in the strongest possible position to deal with the economic challenges we face and to make sure our economy bounces back even stronger.”

Delivering support for business investment

  • $700 million to increase the instant asset write off threshold from $30,000 to $150,000 and expand access to include businesses with aggregated annual turnover of less than $500 million (up from $50 million) until 30 June 2020. For example, assets that may be able to be immediately written off are a concrete tank for a builder, a tractor for a farming business, and a truck for a delivery business.
  • $3.2 billion to back business investment by providing a time limited 15 month investment incentive (through to 30 June 2021) to support business investment and economic growth over the short term, by accelerating depreciation deductions. Businesses with a turnover of less than $500 million will be able to deduct an additional 50 per cent of the asset cost in the year of purchase.

These measures have already started and will support over 3.5 million businesses (over 99 per cent of businesses) employing more than 9.7 million employees or 3 in every 4 workers. The measures are designed to support business sticking with investment they had planned, and encouraging them to bring investment forward to support economic growth over the short term.

Cash flow assistance for businesses

  • $6.7 billion to Boost Cash Flow for Employers by up to $25,000 with a minimum payment of $2,000 for eligible small and medium-sized businesses. The payment will provide cash flow support to businesses with a turnover of less than $50 million that employ staff, between 1 January 2020 and 30 June 2020. The payment will be tax free. This measure will benefit around 690,000 businesses employing around 7.8 million people. Businesses will receive payments of 50 per cent of their Business Activity Statements or Instalment Activity Statement from 28 April with refunds to then be paid within 14 days.
  • $1.3 billion to support small businesses to support the jobs of around 120,000 apprentices and trainees. Eligible employers can apply for a wage subsidy of 50 per cent of the apprentice’s or trainee’s wage for up to 9 months from 1 January 2020 to 30 September 2020. Where a small business is not able to retain an apprentice, the subsidy will be available to a new employer that employs that apprentice.

Stimulus payments to households to support growth

  • $4.8 billion to provide a one-off $750 stimulus payment to pensioners, social security, veteran and other income support recipients and eligible concession card holders. Around half of those that will benefit are pensioners. The payment will be tax free and will not count as income for Social Security, Farm Household Allowance and Veteran payments. There will be one payment per eligible recipient. If a person qualifies for the one off payment in multiple ways, they will only receive one payment.

Payments will be from 31 March 2020 on a progressive basis, with over 90 per cent of payments expected to be made by mid-April.

Assistance for severely-affected regions

  • $1 billion to support those sectors, regions and communities that have been disproportionately affected by the economic impacts of the Coronavirus, including those heavily reliant on industries such as tourism, agriculture and education. This will include the waiver of fees and charges for tourism businesses that operate in the Great Barrier Reef Marine Park and Commonwealth National Parks. It will also include additional assistance to help businesses identify alternative export markets or supply chains. Targeted measures will also be developed to further promote domestic tourism. Further plans and measures to support recovery will be designed and delivered in partnership with the affected industries and communities.

The Government is also offering administrative relief for certain tax obligations, including deferring tax payments up to four months. This is similar to relief provided following the bushfires for taxpayers affected by the coronavirus, on a case-by-case basis.  The ATO will set up a temporary shop front in Cairns within the next few weeks with dedicated staff specialising in assisting small business. In addition, the ATO will consider ways to enhance its presence in other significantly affected regions to make it easier for people to apply for relief, including considering further temporary shop fronts and face-to-face options.

The Government’s economic support package is proportionate, timely and scalable to respond to the economic challenges presented by the spread of the coronavirus.

Through this response and the actions the Government has taken to bring the Budget back to balance over the last six and a half years, Prime Minister Morrison said that Australians can be confident that the nation is one of the best prepared to respond to the economic impacts of the coronavirus.[/vc_column_text][/vc_column][/vc_row]

BIG CORPORATE HEALTH INSURERS CALLED OUT

[vc_row][vc_column][vc_column_text]The ACCC report cities multiple examples where the big corporate insurers have attempted to deny vulnerable Australians access to essential medical treatments, while at the same time raising the price of their premiums.

The report stated that “In 2018-19, private health insurance participants rates continued to decline, while average gap payments for in-hospital and extras treatment increased”.

It also highlighted the fact that “cumulative premium increases have been higher than inflation and wage growth in the past five years, indicating that households with private health insurance are contributing an increasing proportion of their incoming to paying premiums”.

Other industry groups, including the MedTech industry, have slammed the big corporate insurers over their alleged tending ‘policy reform’ as “nothing more than a disturbing attempt to maximise profits over the interests of patients”.

The Medical Technology Association of Australia (MTAA) has said the likes of Medibank, Bupa, NIB and HCF have already undermined consumer confidence in their own products through their “smash and grab” approach to keep their businesses afloat.

The allegation is supported by the ACCC’s instituted proceedings in the Federal Court in May 2017 against NIB where it alleged “it (NIB) contravened the ACL by engaging in misleading or deceptive conduct, unconscionable conduct and making false of misleading representations.” The proceeding arose from NIB’s alleged failure to notify members in advance of its decision to remove certain eye procedures from its ‘MediGap Scheme’ in 2015. Under the MediGap Scheme, members had previously been able to obtain these eye procedures without facing out-of-packet costs when doctors participated in the scheme.

“The Federal Government cannot afford for private health insurers to also now undermine patient confidence in their doctors,” MTAA said in a statement on its website.

Its clear this will not only spell and end to private health insurance as we know it, but irreparable damage to Australia’s healthcare system.[/vc_column_text][/vc_column][/vc_row]

PRIVATE HEALTH PREMIUMS MUST DECLINE IN LINE WITH MEMBERSHIP

[vc_row][vc_column][vc_column_text]Mr Burgess said over 2 million Australians dumped their private health insurance in the last five years and this week’s December quarter APRA figures confirmed this trend was continuing, with only 44.0% per cent of the country now covered.

At the same time, the APRA data shows private health insurance profits before tax increased 14 per cent over the past 12 months from $1.6 billion to $1.8 billion.

This is despite the price of medical devices paid by private health insurers dropping by up to 38 per cent in the past 3 years thanks to government reforms, including another round of recent price cuts on 1 February 2020 for technology treating heart and lung disease, diabetes, bone cancer, severe arthritis and eye trauma.

“It’s clear private health insurers would rather drop customers than drop their prices and profits,” Mr Burgess said.

“Private health insurance premiums have grown faster than national house prices over the past decade.

“It’s a safe bet that the first private health insurer whose premiums go below zero will increase their market share overnight.

“Surely that’s a better investment than health funds spending more on marketing to squabble over fewer customers?

“Private health insurers haven’t paid one extra cent for medical devices over the past two premium years, despite raising premiums twice-inflation and banking nearly $1 billion in profits between the big corporate health funds.

“The number of Australians dropping out of private health insurance is quickly snowballing into an avalanche and it’s time for government to step in and save private health from itself.”

A recent Alpha Beta report identified $1 billion worth of efficiencies that could reduce private health prices by up to 20 per cent within 3 years if government adopted them now.[/vc_column_text][/vc_column][/vc_row]

Medical device price savings for millions of Australians from today

[vc_row][vc_column][vc_column_text]The price cuts are thanks to the Medical Technology Association of Australia’s landmark agreement with Federal

Health Minister Greg Hunt in 2017, which is on track to save $1.1 billion off the cost of medical devices by 2022.

MTAA CEO Ian Burgess said patients continued to get “more for less”, with price drops for about 7000 individual types and brands of medical technologies used in millions of procedures in the private system each year, including:

Condition Med Tech New Price (Feb 2020) Savings (Feb 2020) Savings Since Agreement (2017)
Heart Disease Pacemaker $35,132 -$2,848 -$12,343
Diabetes Insulin Pump $8,574 -$451
Severe Arthritis (Hip) Replacement Joint $8,351 -$393 -$853
Lung Disease Airflow Valve System $5,686 -$299 -$614
Bone Cancer (Leg) Artificial Bone $7,066 -$181 -$428
Eye Trauma Artificial (Glass) Eye $1,741 -$92 -$189

Source: Federal Dept of Health Prostheses List Feb 2020, Nov 2019 & August 2017.

 “This agreement with government continues to help more Australians access more medical technology at less cost.

“That is what I call a win-win-win for patients, taxpayers and industry.

“Today’s announcement also debunks the long-held claim that the cost of individual medical technologies continue to rise, when the vast majority are actually falling in price.

“This is further evidence that when governments work with the medical technology sector, patients get a good deal more.”

Over 3 million medical devices were used to treat Australians with private health insurance last year alone.

Mr Burgess said just like advancements in medicines, medical technology was evolving and becoming as much about improving lives, not just saving them.

“Two of the biggest contributors to Australia’s ill-health are inactivity and isolation – and the two are often linked, particularly as we get older.

“Increasingly medical technology is being used not just to save lives, but keeping Australians more mobile, social, and now, working, for longer, which are all essential to the future health of our ageing population and economy.

“These medical technologies are also continuing to improve patient recovery and operating times, for less cost, meaning better outcomes for the health system and the budget.”[/vc_column_text][/vc_column][/vc_row]