MTAA’s priorities for 2012

Happy New Year from the Board and staff of MTAA and best wishes for 2012. In this first Pulseline for the year I reflect on some of the key issues for the industry over the next 12 months, and MTAA’s areas of focus.

Regulatory reform

December 2011 brought with it the release by the Australian Government of its response to a number of outstanding reviews of the Therapeutic Goods Administration (TGA) in the form of a blueprint for the TGA’s future. It also followed soon after the release by the Australian Senate of the report from  the Community Affairs References Committee inquiring into the regulation of medical devices. While the government has not yet responded to the Senate Committee report, there are several recommendations which align with responses in the TGA blueprint.

MTAA supports many of the proposed reforms to strengthen the regulation of medical devices. MTAA supports the reclassification of the registration class applicable to orthopaedic hips, knees and shoulders from Class IIb to Class III. MTAA also supports proposals to improve the availability of information about regulated medical devices in the way in which a medical device is included on the ARTG and in the availability of product information on the TGA website. We are working with TGA to ensure that the reform proposals are workable and will achieve the review objectives without the imposition of substantial added burden on companies.

MTAA supports reforms to improve the reporting of adverse events by consumers and healthcare professionals. While there are mechanisms available now via the TGA website, they could be improved with greater education on how a user can raise a concern about an adverse experience with a medical device. Similarly MTAA supports the increased availability of data from post market surveillance of medical devices. These are among the recommendations from the Health Technology Assessment review that remain outstanding,also the subject of recommendations by the Senate Committee.

There are additional decisions announced in the TGA blueprint which will require further consideration by MTAA and its members, including the pre-approval of advertisements of medical devices.

Health technology assessment and reimbursement

Reforms to the process for assessment of new medical technologies were gradually rolled out during 2011. These flowed from the review of Health Technology Assessment (HTA) and were aimed at streamlining HTA and reimbursement processes. They were also aimed at ensuring that these processes were consistent with the principles of transparency, accountability, sustainability, and fitness for purpose. MTAA has provided an issues paper to the Department of Health with a series of proposals to improve the assessment processes used by the Medical Services Advisory Committee and will work with the Department of Health to ensure that the HTA principles are applied. MTAA will continue to work through the HTA Consultative Committee to complete the grouping and benefit setting of implantable prostheses on the Prostheses List and progress the development  of policies for the review of benefits and extension of reimbursement coverage to beneficial medical technologies that are not currently eligible for listing.

MTAA is contributing to the shaping of the new pricing arrangements for healthcare delivery under the national health reforms which come into effect on 1 July 2012. For the first time Australia will have a nationally consistent efficient price for the delivery of healthcare in its hospitals. It is critical that the system have the capacity to provide for, and encourage, innovation while meeting the diverse needs of Australian patients, and within a constrained healthcare budget.

Building a sustainable medical technology industry

MTAA will be releasing a major white paper in the first quarter of 2012 with proposals to support the development of a more sustainable medical technology industry with a research and manufacturing base in Australia. Australia is well-placed to nurture the growth of an industry which can help meet the future needs of the Australian healthcare system, as well as provide a base for export into the growing markets of the Asian region. What is missing is policy leadership. Through the work of the NSW Government review of manufacturing, and the Australian Government’s Future Manufacturing Industry Innovation Council, there are opportunities to progress the development of supportive policies. Beyond the manufacturing base there is also a need for greater policy integration between the requirements of the health system for the future health of Australians, and industry-driven innovation and development to meet those needs.

Supporting an ethical industry

MTAA has a strong industry code of practice that underpins the ethical relationships between the industry and healthcare professionals. These relationships are critical for the training of healthcare professionals and provision of information that supports product improvement. However, as the code is not binding on non-member companies there is not consistent compliance with these ethical principles  by companies in the industry. I was extremely disappointed that in its response to a series of unanimous recommendations from a working group established by the government to look at the issue of promotion of therapeutic products to healthcare professionals, in its TGA blueprint the government decided to defer  recommendations which would have strengthened the application of the codes. I note that one of the recommendations from the Senate Committee is for the Department of Health to undertake further work to address the payment of ‘inducements’ by industry to healthcare professionals and hospitals.

2012 will be a challenging year for the medical technology industry, but also a year of opportunity. I look forward to working with you to ensure that Australians continue to benefit from the advances that medical technology contributes to their health.

Anne Trimmer
Chief Executive Officer
Medical Technology Association of Australia

Horten Medical Pty Ltd

Horten Medical is a company providing products and services to the healthcare industry. Horten focuses on the operating theatre, providing quality solutions for public and private hospitals and day surgeries. Horten works closely with surgeons, nurse unit managers and theatre staff to provide products and services which ensure  success and ease of surgical procedures.

For more information, please access this website: www.hortenmedical.com.au

Orthopaedic Solutions

Orthopaedic Solutions is an independent distributor of distal extremities products for Tornier. On our website you will find comprehensive information on all our products, including downloadable surgical techniques. Orthopaedic Solutions provides a comprehensive service including high quality clinical support to all users of our products.

For more information, please access this website: www.orthopaedicsolutions.com

Waterfall Commercialisation (Associate member)

Unlike other groups that specialise in a specific area, the Waterfall Commercialisation Group is a team of medical device specialists that work together with skills in all areas of commercialisation including market insight, product development, regulatory affairs, clinical trialling, quality management, manufacturing and go-to-market activities.

For more information, please access this website: www.waterfallgroup.com.au

MTAA's annual networking function in Brisbane is on Monday 20 February. This function presents an opportunity to learn more about the latest opportunities and trends for the medical technology industry in Australia. It provides time to network with the MTAA Board, CEO and industry colleagues.

Guest speaker Mario Pennisi is the inaugural Chief Executive Officer of Life Sciences Queensland Limited (LSQ). He has been the CEO of the Queensland Clinical Trials Network since its establishment in 2005 and has over 20 years experience in the life sciences industry.

LSQ will work to enhance Queensland’s national and international reputation as a centre of commercial and research excellence in life sciences.

Find out how LSQ can provide an opportunity for the medtech industry to grow their businesses and help create a dynamic, internationally competitive and sustainable life sciences industry in Queensland.

MTAA Chief Executive Officer Anne Trimmer will also give an overview of some of MTAA’s priorities for 2012.

Date:    Monday 20 February 2012
Time:   5.30 pm – 7.30 pm
Venue: Art Gallery, Customs House, 399 Queen Street, Brisbane

There is no charge for this event, but please RSVP no later than Friday 17 February to events@mtaa.org.au or call (02) 9900 0650. Light refreshments will be served.

Register now for the upcoming MedTech Seminar on Pricing Issues and the CNA. Presenter Michelle Somlyay is CEO Catholic Negotiating Alliance (CNA) and Executive Director Funder Relations St Vincent's Health Australia. Michelle will present the following:

• Industry Update and Strategic Challenges/Opportunities in the Private Hospital Environment
• Catholic Negotiating Alliance - an overview
• Catholic Negotiating Alliance – Joint Purchasing Network (JPN)
  o Introducing the new manager JPN
  o The activities of the JPN & their interaction with suppliers of medical technology, pros & cons for the relationship
• Prostheses List and the challenges presented by patient co-payments.

Date: Wednesday 22 February 2012
Time: 4:30 – 5:30 pm followed by refreshments until 6:30 pm (Registration from 4:15 pm)
Venue: Wallace-Freeborn Theatre, Kolling Building, RNSH, Sydney
Fee: Members - $75; Non-members - $150

Please click here to register. Light refreshments will be provided following the presentation.

Please mark your diaries for the following MTAA events in 2012.

Networking Function in major cities:

• 20 February, Brisbane (see above for details)
• 16 April, Sydney
• 13 August, Melbourne
• 4 December, Sydney (Christmas Function)

The MTAA Annual General Meeting will be held on 23 October in Sydney.

The annual conference MedTech 2012 will be held on Thursday 8 November 2012 at Doltone House in Sydney.

Presenter and venue details for the listed events will be announced closer to the date. There will be many more Medtech Seminars, half-day Medtech Forums and other events coming up in 2012. Please keeping checking the newsletters and the event calendar on the MTAA homepage for regular updates.

MTAA is welcoming Alleasing and DHL as annual corporate supporters for 2012. MTAA has changed its sponsorship proposal for the annual conference to an annual supporter model to provide greater benefits to interested companies. Annual supporters will be highlighted throughout the year in a variety of ways, and will also be able to attend MTAA events including the conference.

Members may recall DHL from the Christmas Function last year, now it is Alleasing’s turn to introduce themselves to the medtech sector.

Alleasing, an Australian independent financier with over 25 years experience in the healthcare industry, specialises in the provision of asset finance solutions for their customers. In 2012 Alleasing will be a Silver annual supporter of MTAA.

In the current economic environment with ever increasing pressures on companies’ capital base and capacity to fund capital equipment, Alleasing is offering innovative asset finance solutions to MTAA members and their customers. Such facilities may include:

1. As an equipment vendor or reseller, Alleasing can provide financing solutions to support sales . As more and more of your customers are challenged to fit required (and often critical) equipment under capital budgets they are relying on recurring operating expense budgets to satisfy their acquisition of much needed healthcare equipment. Alleasing can work with you to deliver innovative finance solutions to support your sales process by providing your clients with financing options outside of capital budgets.
2. As a vendor, if you have assets sitting on your own balance sheet (possibly equipment under rental arrangements with your clients) we can provide members with a Sale and Rent Back (SARB) for this equipment. Such a facility will realise immediate cash for these ‘sales’ of equipment and also likely allow the upfront recognition of revenue,which may have previously been capitalised and only recognised over time.  Arrangements can be established to cater for future sales under such a rental solution to your customers and this helps with any upgrade path as technology changes and devices need to be replaced.
3. Alleasing also works with a major Australian bank to provide our clients with funding solutions for trade receivables. We want to gauge the demand from MTAA members for such facilities, and if demand is there potentially establish a facility to support the sale of trade receivables.We can provide you with an information pack. All information provided will be treated as commercial-in-confidence.

As an annual supporter Alleasing will provide more offerings to MTAA members. For any further information please contact either David Gordon (P: 02 9850 5122 or E: david.gordon@alleasing.com.au) or Diana Khodr (P: 02 9850 5123 or E: Diana.khodr@alleasing.com.au).

What’s New?

The MTAA 2012 Training Calendar is on its way to your desk. If you haven’t seen a print copy yet, please click here to access the calendar online.

Two new modules within the 5.0 Workforce Development course are currently in development and will shortly be available as self-paced online learning. Module 5.11 Planning Projects will explore general project management principles and how to apply these skills to the project planning processes during the initiate and plan phases. With the introduction of the federal Work, Health and Safety (WHS) Act 2011 effective from 1 January 2012, module 5.12 WHS Fundamentals will support employees to gain an understanding of these principles, including workplace safety when working offsite in healthcare facilities. To register your interest for either module, please E: pd@mtaa.org.au

Upcoming Training

For a snapshot of upcoming training, please click here.

February
1.1 Introduction to the Regulation of Medical Technology (17 February, Sydney)
3.5 Introduction to Operating Theatre Protocols (17 February, Sydney)
2.2 Complying with the Code of Practice (29 February, Sydney)

March
3.5 Introduction to Operating Theatre Protocols (12 March, Brisbane)
4.2 Achieving a Successful Application for the Prostheses List (30 March, Sydney)

April
1.2 Advanced Review of the Regulation of Medical Technology in Australia (20 April, Sydney)
3.5 Introduction to Operating Theatre Protocols (20 April, Sydney)

E-learning

As more healthcare facilities regulate MCRs providing evidence of ACORN approved training, companies are continuing to register their experienced MCRs who regularly enter the perioperative environment to complete module 3.6 Operating Theatre Protocol Update online. To register your company for module 3.6, please click here. Following the successful completion of the module, MTAA will issue participants an e-Certificate of Participation and photo ID card valid till July 2012, in line with the next review of the standards.

Contact Details

If you would like to know more about other training opportunities that are available through MTAA, please contact Fiona Shipman, Professional Development Manager, by E: pd@mtaa.org.au or P: (+612) 9900 0650.

The NSW Government has scheduled Public Consultation Forums as the next step in the process for the development of the NSW Manufacturing Action Plan. They will be held in the following locations:

• Wollongong (13 February)
• Newcastle (6 March)
• Sydney (12 March)

Forums are also being planned for February/March in Orange, Coffs Harbour, Albury and Western Sydney.

Chair of the Taskforce, Andrew King of Capstone Partners will open the session followed by roundtable discussion of priority issues to inform the recommendations.

For more information about this process please contact MTAA Industry Policy Manager Fiona Landis by E: flandis@mtaa.or.au or P: (02) 9900 0650, or click here: http://haveyoursay.nsw.gov.au/iap-manufacturing

The Australian Commission on Safety and Quality in Health Care is undertaking a stock take of health literacy initiatives undertaken in Australia to date. The Commission is seeking information on initiatives that aim to improve health literacy and those targeted toward changing the healthcare environment or systems to reduce complexity and lower demands on consumers.

The Commission is seeking information on initiatives, projects or programs that focus on improving healthcare by:

• targeting the health literacy of patients, consumers, families, carers and/or health care providers
• changing the healthcare environment or systems in order to reduce complexity and lower demands on patients and consumers, and remove health literacy barriers.

You can follow this link to submit your company information online: https://www.research.net/s/ACSQHCHealthLiteracyStocktake

Written submissions should be addressed to:
Naomi Poole (ACSQHC)
MDP 114, GPO Box 5480
SYDNEY NSW 2001
or email ACSQHhealthliteracystock@health.gov.au

The Commission will be accepting information up to Friday 30 March 2012.  Replies should be titled “Health Literacy Stocktake.”

Do you advertise therapeutic goods to consumers?

The Therapeutic Goods Advertising Code Council is running a series of seminars in 2012 on the advertising of therapeutic goods to consumers. If you are interested in attending one of the seminars, please visit the TGACC website at www.tgacc.com.au for the schedule and registration details.

German Trade and Investment

Mark the date for two events on 13 March (in Sydney) and 15 March (in Melbourne) promoting Health Made in Germany. This German export initiative is funded by the German Government and managed by German Trade and Invest, the Consulate General and the German-Australian Chamber of Industry and Commerce. MTAA has been assisting in the organisation of the events with a range of senior representatives from member companies speaking at the event. More details about the individual events will be available soon. For more information about the initiative, please follow this link. 

Global GS1 Healthcare Conference

The 21st Global GS1 Healthcare Conference When Supply Chain meets eHealth - The importance of laying the foundations in healthcare will be held on 20 - 22 March 2012 in Sydney.

This conference will provide a unique platform for healthcare colleagues from around the world to meet, exchange experiences and advance the implementation of global standards – to increase supply chain efficiency and patient safety.

More information is available here.