Dear %%First Name%%,

Members will be delighted to hear that IVD Australia has been invited by the Department of Health and Ageing to submit a nomination for the revised Pathology Services Table Committee (PSTC). This Committee will provide the technical support to MSAC and the Minister in matters pertaining to the Pathology Services Table and on the inclusion of new or revised pathology items on the Medical Benefits Schedule. The Department is currently reviewing the nominations and an announcement is expected with the next several months.

Members will however not be pleased to hear that there are likely to be cuts to pathology reimbursement under the 2011 Pathology Agreement. Medicare expenditure for pathology has been running ahead of the agreed targets at ~ 6.5% growth and it is understood that the Pathology Agreement Advisory Council (AAPP, RCPA, NCOPP and DoHA) are negotiating reductions in MBS fees for implementation in November. Members should brace themselves for these cuts to be reflected in prices that the pathology sector are prepared to pay for tests.

Nominations for the vacant IVD Australia Board positions closed on 17th August. I can report that we had 3 nominations for the 3 positions available, meaning that I can declare these nominees duly elected;

• Mr Bruce Evans, Abacus ALS
• Ms Holly Simmonds, Hologic
• Mr Patrick Cook, Macarthur Cook Group

The new Board will meet in Melbourne on 18th October following the AGM and elect the Office Bearers for 2012/13   

Finally, IVD Australia is on the move as we have outgrown our serviced office (who are doubling the rent as well). We will be changing premises in late August to our new address in Phillip St  - Suite 2, Lower Ground, 55 Phillip St, Parramatta, 2150. There will be no change to our other contact details or to our email but the new office will give us access to our own Board Room / Meeting Room and Training facility.

 IVD Australia AGM and Networking Dinner  - has been confirmed for Wednesday 17th in Melbourne - location to be announced shortly. Please save the date.

 However we can confirm that the Parliamentary Secretary, Hon Catherine King MP, has agreed to speak to members at the AGM. We will be holding a Networking Dinner following the AGM and plan to present to Members on the "Value of Pathology" initiative that we recently announced. As part of this we have also invited representatives of a number of pathology stakeholders to attend and join in the presentation. So we need as many members as possible to join us in Melbourne.

IVD Australia Website - has been updated recently with a new skin and several new features including a countdown timer to the end of the IVD Transition period. As of today, there are only 678 days to the 30th June 2014. However for those products that will require a TGA Conformity Assessment Certificate you have far less time than this to commence the process. TGA is currently taking over 15 months to issue these.  Remember that Class 4 and Australian manufactured products will require a TGA CA Certificate to be issued prior to making a valid application for inclusion so you have less than 6 months to start the process with these products. 

IVD Australia Training - members will be aware that we have run our Introductory Training Program 3 times this year and the Conformity Assessment Training twice. At this time we are proposing to run the Introductory Training in March 2013 but have not scheduled the Conformity Assessment Training. Members who are interested in either of these courses should contact Glenda and advise so we can determine if further dates are required.

TGA Sponsor Training Day - we are still seeking feedback on the Sponsor Training Day held in Canberra on 22nd June. Specifically, we would like to hear your opinion on the IVD sessions. If you have further input, send your comments directly to Peter.

 TARSC - met on 3rd August. Among the issues discussed were the slowness of TGA in approving applications particularly for Class 3 and 4, the issues associated with getting correct invoices from the TGA, and timeframes for the medical device reforms.

PoCWG - the Point of Care Working Group met also on 3rd August. The main topic was IVD Australia's participation at the Australian College of Rural and Remote Medicine (ACRRM) Conference in Fremantle in October. IVD Australia will be represented with a trade display featuring point of care equipment and tests but we will also be running a 2 hour workshop and practical demonstration on point of care testing in rural and remote locations, featuring the features of modern PoCT equipment and tests. We already have 5 member who will be demonstrating their equipment. The ACRRM Exhibition is already sold out but members are encouraged to register and attend the meeting.

In-house Assays Working Group - this ad-hoc group will be reviewing the NPAAC standard on in-house IVDs shortly - see below for further information.

 TGA - the Parliamentary Secretary, Hon Catherine King MP, announced recently that the Government would establish an Australian Therapeutic Goods Advisory Council later this year to provide broad strategic advice to the Therapeutic Goods Administration (TGA), with an emphasis on improving communications between the regulator and its key stakeholders. The Council would compromise around 10-12 members of which 3 or 4 would be from the various health industry sectors (medicines, medical devices and OTC and complementary medicines). It would be chaired by Australia's Chief Medical Officer, Professor Chris Baggoley.

IVD Business Rules for Fee Reductions - TGA has also released an update to the Guidance document on IVD Business Rules. This change is to bring IVDs in line with other medical devices such that the fee reductions are a percentage of the full fee. Most fees under the new rules will not change significantly from the previous Guidance.

GMDN Preferred Terms - members who will require GMDN preferred terms for inclusion in the ARTG are reminded that at present TGA can create these for free. However past 1 July 2014 manufacturers will need to apply to the GMDN Agency and pay to have them created before a product can be included on the ARTG. So there is a significant incentive to create any preferred terms that you may need for your current assays over the next 18 months. Contact the TGA (Fiona McCormack) for more information.

TGA IVD Industry Working Group - met on 8th August in Canberra at which the progress of applications along with a number of other important issues were discussed including;

• the level of information required for reduced fees for Class 3 inclusions
• use of IAF certified ISO 13485 as manufacturers evidence
• MOU with Canada - removal of documents from the TGA website
• the delay in getting CA certificates - currently there are 20 under review
• in-house IVDs and the release of the in-house assay database prior to July 2014

TGA is still concerned about the level of applications, particularly for Class 4, but the numbers have jumped substantially over the last 6 months.

Review of the URPTG -  the TGA will be undertaking a review of the Universal Recall Procedure for Therapeutic Goods (URPTG) some time in the near future, given that the last review was in 2004. While there is not a definite date for this, it might be a good time for members to review the URPTG  and to think about the possible changes they would like. Any suggestions should be passed to Peter for compilation. If you don't have a copy handy, the URPTG can be downloaded from the TGA Website.

Low Volume Low Value - members who have existing registered or listed IVDs (under the DR4 rules) are reminded that the deadline for submission of their LVLV applications is September 1st 2012. There is no ability for the TGA to extend this date so members must get their forms (download here) in on time.

TGA Public Contact Pilot - TGA has begun a pilot project to investigate how it can more effectively respond to phone calls and email enquiries. This work is being undertaken by TGA staff in a dedicated Public Contact Team (PCT).

From 16 August 2012, calls to the TGA's main Information Line number (1800 020 653) and generic email address (info@tga.gov.au) are being handled in the first instance by a TGA staff member working in the PCT. All other 1800 numbers and generic email accounts will continue to be handled by individual areas. The pilot is scheduled to run until the end of 2012.

AQIS - the Department of Agriculture, Forestry and Fisheries (DAFF) which is responsible for quarantine matters has announced that the exposure draft period for the NEW Biosecurity Bill has started. There is information on the DAFF homepage including a link to the govspace page (http://biosecurity.govspace.gov.au/) where most of the materials will be hosted throughout this period. Note that not all chapters of the Biosecurity Bill have been released, the incomplete chapters will be released once ready. This Bill is an overarching one which sets up the framework for the Regulations - as always, the devil will be in the details.

NPAAC - as members will be aware, IVD Australia has been eagerly awaiting the release of the NPAAC Standard on the Requirements for the Development and Use of In-house In Vitro Diagnostic Devices; otherwise known as "home brews". The draft consultation document was released in mid July along with several other Standards, and the in-House Working Group will be submitting comments by the August 31 deadline. Any IVD Australia member is welcome to send their comments by 20th August to Peter for consideration.

 AACB Conference - we are still seeking companies to participate in the Lab Tours visits on Wednesday 14th November. We are also seeking exhibitors to participate as well in the Exhibition Guided Tours to be held at lunchtime during the Conference itself. These will give you the opportunity to present for 10 minutes on what's new and interesting on your stand to a captive audience of delegates Please contact Lisa King at AACB directly or you can advise Peter of your interest

Dark Daily - has recently made a visit to deepest, darkest New Zealand for the 2012 Pathology Laboratory Meeting that is conducted annually by Canterbury Health Laboratories (CHL). Robert was quite impressed especially with the resilience of the Christchurch lab in moving 6 times since the original earthquake. If you are not a subscriber to Robert's newsletters you can read the comments on NZ Pathology here and here.

EDMA - it has recently been announced that EDMA (European Diagnostics Manufacturers Association) and EUCOMED (the medical device equivalent) will be joining forces in an alliance to strengthen their joint approach to medical device regulation. To this end they have recently appointed a joint CEO, Serge Bernasconi, as Chief Executive of both Associations. Luciano Cattani at Eucomed and Volker Oeding at EDMA both stepped down from their respective roles on 16 July 2012.

EDMA - have also recently announced the Lab Tests Online website has been recognised with an Award of Distinction in the 18th Annual Communicator Awards for writing in the website category. This confirms its position as one of the premier healthcare information resources online. The Communicator Awards is the leading international awards program that recognizes big ideas in marketing and communications. Members should be aware that the Australian LTO site is maintained by AACB with the support of RCPA and the assistance of a grant from DoHA.

HealthPact - have released their quarterly Bulletin covering emerging medical technology issues. You can download it here. 

IMDRF - the next meeting of the International Medical Device Regulators Forum (IMDRF) will be in Sydney on the 25-26th September at the Pullman Hyde Park Hotel (formerly the Marriott). The 2nd day (26th) will be an open forum to which all medical device and IVD stakeholders are invited. To register contact the IMDRF Secretariat by 29th August.  

NPC GS1 Supply Chain Conference - as part of Supply Week NEHTA and GS1 are running some information sessions on the NPC and related topics. There are two different events:

• 10th September - Solution Provider Showcase – this event involves case study presentations from Solution Providers who have helped suppliers implement the NPC and eProcurement
• 12th /13th September - Supply Chain Seminars – morning seminars run in Melbourne and Sydney that are designed to help suppliers get started on the NPC

Further details are available at the GS1 website.

NEHTA Procurement Intentions - as a part of NEHTA’s Supply Chain Reform Programme Review conducted in 2011, suppliers indicated that they were unclear as to how their product data loaded on the National Product Catalogue (NPC) was being used by Australian Healthcare Buyers. Accordingly, NEHTA have developed an Intention Statement, the purpose of which is to provide pharmaceutical, medical product and consumable suppliers, manufacturers, wholesalers, distributors, etc. in the Australian healthcare market with a snapshot of current NPC and eProcurement activities in the public and some private healthcare provider market.

It is NEHTA's intention to update and release a quarterly edition of the Intention Statement to keep the market informed as to current and future use of NPC data (both for accessing product data with GTINs as well as using the GTINs and GLNs as the foundation for eProcurement activities). Feedback, questions or comments are always welcome and can be sent to Mark Brommeyer, Manager Supply Chain.

RCPA ePathway - RCPA have released the July edition of their ePathway newsletter. You can read /download it from the RCPA website.

Lab Equipment for Zimbabwe - Anne Trimmer ( CEO, MTAA) has recently joined the board of Plan International Australia, an NGO which provides child centred development assistance. Recently she was in Zimbabwe with the Board on a field trip visiting some of the programs they have underway in rural areas of the country. At the end of the week they had a reception at the Australian Ambassador’s residence at which Anne met an Australian obstetrician who talked to her about identifying the type of equipment and tests which might be required to re-establish a neonatal side lab at Harare Hospital. Anne thought IVD Australia members might be able to assist with the technical information. His comments were as follows;

"I am following up on our discussion at the embassy reception in Harare regarding the re-establishment of a side lab at the neonatal unit at Harare Central. The neonatal unit, which is the largest tertiary referral unit in Zimbabwe, had a fully equipped side lab at the time of its establishment in the 1980’s. However, during the political/economic crisis which engulfed this country in the last decade, all of the lab equipment fell into disrepair and the lab ceased to function.

Now that the economic situation has stabilised, we are currently in the process of seeking donor funding to restore the lab. We would therefore value your organisations advice on the type and make of equipment we should purchase. We hope, at a minimum, the laboratory will be able to carry out the following tests: U&E, FBC, serum bilirubin, LFTs and blood gases. The lab will not have full time laboratory staff and the equipment will be operated by nurses and doctors. Therefore it needs to be relatively simple to operate, robust and easy to maintain. Your technological expertise on the most cost effective options open to us would be greatly appreciated. It’s possible that funding for the purchase of equipment may come from Australian sources".

Any IVD Australia members would like to comment on this request or can assist with sourcing suitable equipment are encouraged to contact Peter to discuss their thoughts on this.