Regulatory reforms – government response to HTA Review

Last Friday TGA released the first tranche of reforms in response to the Review of Health Technology Assessment. Following the government’s acceptance of a recommendation which called for an increase in the rigour of regulatory assessment of higher risk medical devices, to ensure that an appropriate level of evidential review is undertaken to ensure safety, quality and efficacy of these devices prior to entry on the Australian Register of Therapeutic Goods (ARTG), TGA has proposed three reforms:

• Reclassification of orthopaedic hips, knees and shoulders from class IIb to class III
• Changes to the way in which a medical device is identified on the ARTG to provide greater visibility of individual products
• Increased public availability of information about a medical device, specifically higher risk devices.

MTAA has generally supported the reform moves. The challenge will be in implementation. MTAA acknowledges that the proposed transitional provisions should assist companies to move to the new regulatory requirements although there are areas of detail which will need to be negotiated. The timeframe is tight with a stated intention that the regulatory changes be operational from 1 July 2012.

The second tranche of reforms, which include consideration of third party conformity assessment, awaits the outcome of this week’s inquiry by the Senate Community Affairs References Committee. Key themes from submissions, and from witnesses appearing before the Senate Committee, have included reconsideration of the information provided to support inclusion of a product on the ARTG, and improvements in post market surveillance such as increased availability of data on product performance (from registries and from other sources). In appearing before the Senate Committee, MTAA emphasised that there must be recognition that Australia is a small market and that reforms must be consistent with comparable markets to ensure that Australian patients continue to have access to beneficial innovative technologies.

Anne Trimmer
Chief Executive Officer
Medical Technology Association of Australia

On 26 September MTAA responded to the NSW Health and Medical Strategic Review Issues Paper examining mechanisms to support collaboration with industry to encourage the translation of excellent research into products that can be brought to the market, both to benefit the NSW health system and its patients and to deliver flow-on economic benefits from the creation of a robust manufacturing sector that exports globally.

The medical technology industry is one of the few manufacturing sectors in Australia demonstrating economic growth. The translation of research into economic benefits cannot be achieved without industry partnership. Even through the majority of medtech companies are based here, NSW to date has missed out on medical device commercialisation opportunities due to insufficient government support.

MTAA supports the development of a life science cluster in Sydney, using the existing concentration of medical technology companies, as well as pharmaceutical and biotechnology companies, in North Ryde and Macquarie Park, and leveraging the world class research projects at various institutions in NSW.

MTAA believes government should invest in a Medical Device Fund, particularly targeted at small and emerging companies, to ensure research ideas that have potential for rapid health benefits are captured at the critical early commercialisation stage. A copy of the submission is available from the MTAA website.

Early bird registration for the MTAA conference MedTech 2011: Medical technology – building sustainable healthcare has been extended until Friday 14 October 2011.

Please follow this link to register online now!

The conference and Kerrin Rennie Dinner is scheduled for Tuesday 8 November 2011 at Doltone House, Sydney.

MTAA wishes to thank the major sponsor Pharmaceutical & Medical Professionals and sponsors Healthcare Placement Solutions and Persona Grata Consulting for their generous and ongoing support of the conference.

Program Updates

Plenary speaker Dr Tony Sherbon, Acting CEO of the Interim Independent Hospital Pricing Authority, will be presenting on the Australian Health Reform – preparing for the future.

Dr Sherbon is currently working on the establishment of the Independent Hospital Pricing Authority agreed at the Council of Australian Governments meetings held in April 2010 and February 2011.

Before taking up his current position in September 2011, Dr Tony Sherbon had 21 years experience in clinical and administrative management within the NSW, ACT and South Australian health systems. He previously oversaw the design and implementation of the SA Government’s Health Care Plan in his previous role as Chief Executive of SA Health.

Dr Sherbon has previously chaired the Australian Health Ministers Advisory Council, and has been a Board member of the South Australian Health and Medical Research Institute, National E-Health Transition Authority and Health Workforce Australia.

Joining the CEO Forum will be Dr Gilman Wong, CEO of Sirtex Medical Limited.

A program and list of speakers is available from the MTAA website or in the program brochure.

Training Needs Analysis

Last chance to participate in the annual Training Needs Analysis (TNA) survey. If you are working in a PD or HR role, or would just like to participate in the TNA, please click this link to complete the online survey. The survey closes TODAY, 30 September 2011.

Communicating Effectively with Healthcare Professionals

Do you work directly with healthcare professionals? Do you wish you could speak their language to be more successful in getting your key messages across?

Join this practical and hands-on one-day training to acquire skills, knowledge and understanding that will enhance your interactions with healthcare professionals.

Your presenter is Professor Stewart Dunn, clinical psychologist and Professor of Medical Psychology from the University of Sydney. After a brief introduction the fun begins with actor Renee Lim who will work through a series of scenarios with participants. Renee brings extra experience to this training in that she is both, a professional actor and practising doctor.  You may know her from TV series such as Crownies, East West 101, Packed to the Rafters and All Saints.

The training will involve opportunities to interact through role-plays in a supportive learning environment. The scenarios will address communication challenges encountered by medical technology personnel when working with surgeons and physicians. The workshop will explore both situations that occur frequently and are difficult to manage, and others that may occur rarely, but can really put a spanner in the works. During the role-plays participants will receive helpful feedback from Professor Dunn.

Staff interacting directly with surgeons and physicians should participate in this face-to-face module scheduled for Wednesday 14 December 2011 in Sydney. Places are limited.  Please register online for the training .The cost of this one day module is $950 for members and $1500 for non-members (including GST).

Upcoming Training

For a snapshot of upcoming training, please click here.

October

• 5.11 Managing Work Priorities and Delegation (12 October, online)
• 3.5 Introduction to Operating Theatre Protocols (21 October, Melbourne)
• 2.2 Complying with the Code of Practice (26 October, Sydney)

November

• 3.5 Introduction to Operating Theatre Protocols (7 November, Brisbane)
• 5.12 Implementing a Workplace Wellness Program (9 November, online)

December

• 3.5 Introduction to Operating Theatre Protocols (9 December, Sydney)
• 3.8 Communicating Effectively with Healthcare Professionals (14 December, Sydney)

Code of Practice E-learning

Module 2.1 Introduction to the Code of Practice (Edition 6) is only available online. Members and non-members are encouraged to complete the training. Please click here to register your company.

Contact Details

If you would like to know more about other training opportunities that are available through MTAA, please view the interactive training promotion. For all professional development enquiries, please contact Fiona Shipman, Professional Development Manager on pd@mtaa.org.au or (+612) 9900 0650.

The international trade fair Medica, one of the largest fairs in the medical industry will take place from 16-19 November 2011 in Dusseldorf, Germany.

The NSW Government will have a stand at the fair and any interested companies can contact Crista Bracamonte at the Department of  Industry and Investment on  crista.bracamonte@business.nsw.gov.au  or 02 9338 6652 for more information.