Value-Based Healthcare Summit

In April MTAA will be hosting a Value-Based Healthcare Summit which will bring together policymakers, healthcare and industry leaders for a day long program focused on how the shift towards value-based health care agenda will impact the medical device sector.

The Summit will provide a setting to discuss and examine the complexity of the issue, share solutions and strategies for the way ahead.

Sessions will include:

+ Value-Based Healthcare in Australia
+ Capturing Real-World Data to Assess Value
+ MedTech industry can collaborate with stakeholders to leverage the power of big data
+ Measuring Outcomes in Healthcare
+ Value-Based Healthcare in the Public & Private Sector
+ Shifting from Volume to Value
+ Value-Based Procurement
+ What value means in Healthcare: A Patient Perspective
+ Value-Based Reimbursement of Medical Technology
 
Register your attendance to the Summit on the 24th April at Medtronic in Macquarie Park and gain the early bird discount (ending Friday 23rd March):

MTAA Non-member   $405
MTAA Member            $324

New Digital Platform to launch this year

MTAA is developing a digital platform as part of an initiative to better engage with industry, government and the public. A key component of the digital platform will be the production and distribution of industry positive insights, news and information.

If you have any questions, would like to know more or would like to contribute please contact MTAA Communications & Government Affairs Manager Polo Guibert-Wright.

Are your OTP standards up to date?

New Introduction to Operating Theatre Protocols courses have been announced for Sydney, Melbourne & Brisbane for 2018. Get ahead of the queue and book early!

1.5 Introduction to Operating Theatre Protocols 27 February 2018, Brisbane

LIMITED PLACES

1.5 Introduction to Operating Theatre Protocols 8 March 2018, Melbourne 

POSTPONED FROM 9 FEBRUARY 2018

1.5 Introduction to Operating Theatre Protocols 23 March 2018, Sydney

COURSE OPEN

Parliament starts 2018 much like 2017

2017 ended with a by-election in Bennelong and 2018 starts with another by-election in Batman. But this unlikely to be the end of the dual citizenship fiasco that has plagued the Parliament. We have a number of new Senators, including Kristina Keneally replacing Sam Dastyari, Jim Molan replacing Fiona Nash and the High Court finding Steve Martin eligible to replace Tasmanian senator Jacqui Lambie.

The first Newspoll of 2018 continued the trend in 2017 of Labor being in an election winning position. The government has closed the gap, but the margin is 52-48 in favour of Labor despite signs voters are drifting back to the Coalition from One Nation.

Bill Shorten delivered a National Press Club speech in which he outlined a number of policy priorities for the Labor Party around the cost of living. But it is his attack on the private health insurance industry that drew a quick rebuke from the sector. Bill Shorten, and Shadow Health Minister, Catherine King, subsequently announced a number of policy proposal for an incoming Labor government that included a review of private health insurance by the Productivity Commission and capping premiums at 2% for two years.

This week Fairfax reveals the government will take a tough line with state governments demanding big boosts to public hospital funding on Friday, in a move that will risk reigniting a fight with the states. But Health Minister Greg Hunt will argue billions of dollars of extra money will be on the table to secure a new funding agreement.

Department of Agriculture issued alert on 'stink bugs'

The Department of Agriculture has issued an alert that all incoming containers from Italy now have to be fumigated or treated to reduce risk of ‘stink bugs’ coming into Australia as per the following: www.agriculture.gov.au/import/industry-advice/2018/04-2018

We understand an exemption applies to “Fresh produce (including nursery stock and live plants); Live animals; Food for human consumption; Seeds for sowing”; and the pharmaceutical industry.

We are asking for an exemption for medical devices is based on the following:

• Medical devices are largely invasive ie. implanted in the human body or used directly in the body during surgical procedures;
• Medical devices are required to be manufactured, transported and stored with in tight environmental controls;
• The environment in which a medical device is manufactured, transported and stored needs to be validated to ensure any risks to patients are as low as possible and clearly characterised;
• Changes to that environment would need to be validated to ensure no detrimental effect to the finished medical device or transfer of contamination to the patient;
• The addition of a “chemical” to a medical device would need to be validated, prior to application, as an understanding of any residuals is required to ensure patient safety and device integrity;
• These residuals have not been evaluated from a toxicological risk point (across any medical device) and would therefore mean the product no longer conforms to the strict provisions under which it is approved to be supplied in Australia. Non-conformance results in the destruction of product – no Australian patient would receive the device;
• Many medical devices are provided sterile and if sterilised by a gas sterilisation process, there is a potential for any chemical to enter the sterile barrier which is designed to allow gas ingress;
• The controls on medical devices are critical to patient safety as any residuals may enter a surgical open wound site and/or used in patients who are immune compromised;
   

At this stage the Department is not willing to provide our industry with an exemption as it does not have enough evidence or understanding of our sector. If you are impacted by this issue please contact MTAA so that we can put you in touch with the right people in the Department. We hope that by understanding and inspecting the goods the Department might be better placed to provide our sector with an exemption.

Therapeutic Goods Amendment bill brought to the Senate

Last week the Senate Community Affairs Committee recommended the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and related Bills be passed by the Senate.

These Bills primarily implement reforms flowing from the expert panel review of medicines and medical devices, known as the Sansom review. This is the second tranche of legislation following the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, which was passed in the middle of last year.

The committee acknowledged the significant amount of consultation involved in the years leading up to the introduction of this bill, including through the Medicines & Medical Devices Review, as well as the time and detailed work undertaken to ensure that the proposed reforms are appropriate.

Some recommendations include:

• The Therapeutic Goods Administration (TGA) continues to carry out comprehensive, appropriate and timely consultations with industry and other key stakeholders.
• The importance of self-regulatory models by industry.
• Government ensures that the TGA is adequately resourced.
• The Senate debated the Bills on Monday 5 February and MTAA expects these Bills to be cleared for Royal Assent shortly.

Briefing on European MedTech Forum 2018

The European MedTech Forum 2018 was held between 23-25 January in Brussels. Val Theisz, Director of Regulatory Affairs, attended on behalf of MTAA.

Over 90% of medical devices in Australia are included in the ARTG based on EU CE Marking approvals, hence a major area of interest for us in Australia is the new EU Medical Device Regulation (MDR) for medical devices and the Notified Bodies re-designation to the new MDR.

The TGA will not be able to continue to accept EU CE Marking approvals unless Australian medical device regulations remain aligned with the EU regulations, (i.e. unless Australian regulations align with the MDR). The expectation is the TGA will align Australian regulations with the EU Medical Device Regulations.

For more information, please speak to MTAA Director of Regulatory Affairs, Val Theisz

Innovation and Science Australia (ISA) releases 2030 Plan

Innovation and Science Australia (ISA) has challenged Australians, and their governments, to be bolder in using innovation to unlock economic and social opportunity for the future.

The call came as ISA Chair, Mr Bill Ferris AC, launched Australia 2030: Prosperity through Innovation(the 2030 Plan) with the Minister for Jobs and Innovation, Senator the Hon Michaelia Cash, at Astor Industries in Western Sydney.

Australia should use ambitious ‘National Missions’ to strengthen Australia’s innovation culture and demonstrate that Australia’s world-class innovation, science and research system can be used to solve some of the biggest global challenges of the coming decades, according to one of the 2030 Plan’s recommendations to Government.

Earn your regulatory affairs qualification online in 6-12 months

Developed by industry experts, the University of Wollongong’s Graduate Certificate in Regulatory Science is an online course that will give you the qualification you need as a regulatory affairs specialist.

This course, which can be completed in 6 or 12 months, will help you:

• Build a portfolio of practical experience in navigating regulatory frameworks that you can apply at your firm.
• Get industry-focused applied course content, delivered by industry experts.
• Understand how quality management systems can generate competitive advantage for your firm.
• Get ahead of the potential industry changes to regulations, which may require university qualifications.
   

UOW has government subsidised places available for domestic students studying this course (see Commonwealth Supported Places).

Enquire and apply online now. Starts March 2018.

17th National Health Insurance Summit: 31 May - 1 June 2018

The 17th National Health Insurance Summit will provide discussion on legislative reform, regulatory changes, and the future direction of the Private Health Insurance (PHI) industry.

Recent reforms mean the PHI industry has the opportunity to overhaul the current system to provide a higher level of transparency and affordable value for consumers.

The summit will bring together senior level representatives to address current challenges, as well as offering new strategies and solutions to appeal to their members.

Topics to be addressed include:

• Improving Transparency Around Medical Out-of-Pocket Costs
• Declining Health Insurance Membership
• The Future Buyers: How Valued-Based Healthcare Will Impact the Medtech Industry
• What is Really Driving PHI Premium Increases-What Can we do About It?
• Future Innovations for Private Health Insurance
• Changing Health Insurance to Target Millennials
• New Channels for Distributing PHI
• Dealing with Government Policy and Regulator Risk
   

Confirmed speakers to date include:

• Dr Rachel David, CEO, Private Healthcare Australia
• A representative from Australian Prudential Regulation Authority
• Ian Burgess, CEO, Medical Technology Association of Australia
• Christopher Zinn, CEO, Private Health Insurance Intermediaries Association 
• Matthew Koce, CEO, Members Health Fund Alliance
  

Australian National Digital Health Summer Summit 2018

The full speaker lineup is confirmed for the ANDHealth 2018 Summer Summit 

"Commercialisation and Capital in Digital Health" 

Hear from international and national industry leaders as they discuss global technology trends, digital health business models, valuation challenges and participate in a no-holds-barred investor Q&A, plus a showcase of emerging Australian digital health companies participating in the ANDHealth+ program.

Keynote Speakers:

Bill Hunter – Cardiome Pharma Corp, Canary Medical

Oxana Pickeral – Global Segment Leader, Amazon Web Services

DATE: Wednesday 21st February 2018, 8:00 am – 6:30 pm AEDT

VENUE: Allens, 37/101 Collins St, Melbourne, VIC 3000

NSW Medical Devices Fund 2018-19

The Medical Devices Fund (MDF) is a competitive technology development and commercialisation program. In the 2018-2019 financial year the Fund has over $8 million available to help support investment in the development and commercialisation of medical devices and related technologies.

All applicants are required to complete the online self-assessment survey online prior to submitting a preliminary application form.

To find out more about the MDF application process and guidelines, please visit the NSW Department of Health website.