Dear %%First Name%%,

Welcome to a new Financial Year - I trust it will be a sucessful and profitable one for all members.

Over the last few months IVD Australia has been busy in organising a meeting of stakeholders in the patholgy sector to create a group to look at the promotion of the value of pathology testing. I am pleased to advise that we have formed the "Value of Pathology" Alliance with 7 initial members and seed funding. The intention is to develop a program focussing on informing disease groups and consumers of the benefits that pathology testing brings to them and their families, and to emphasise the value that this provides to the community. We are hoping to create a promotional program commencing in early 2013 and running for 3 years when the next Pathology Funding Agreement is due for negotiation.  

Unfortunately, members will be disappointed to learn we received news late last week that the campaign conducted by the health sector associations to reduce the increase in TGA Fees and Charges for 2012/13 was not sucessful. The Governor in Council on Thursday (28th June) approved a rise of 5.6% in TGA Fees and Charges that incorporates an increase of 3.6%  as a result of CPI as well as an increase of up to 2% to cover the cost of the TGA Reform program. Whilst IVD sponsors do not generally pay Annual charges at this time (see below), Application fees and Technical File Review charges under the IVD Regulations will increase and this will definitely affect IVD Australia members.

These increases will add to the base cost of TGA Annual Fees when IVD ARTG entries do attract an annual charge in 2014/15. The health sector associations are writing to the Prime Minister, the Health Minister and the Finance Minister as well as the Parliamentary Secretary expressing our extreme disappointment at this decision and asking for a cost impact recovery statment to be prepared.

Finally, June 30 represented the halfway point of the 4 year IVD Transition period. Sponsors now have ONLY 728 days to ensure that their IVDs are included on the ARTG, and certainly if they have one that will require a TGA Conformity Assessment,  considerably less than that to commence their application.

As of today there were 492 ARTG entries included under the new regulations (Hint:- go to the ARTG and search using the term "IVD*"). but there were still over 430 IVDs included under the old regulations (Search using "Human and not IVDs"). It should be noted that those listed or registered products will attract a TGA Annual Charge of $740 as of yesterday so if you have transitioned these products then go in and cancel the listing. You will still have to pay the 2012/13 Fee now as they have been on the ARTG for 2 days in a Financal year but at least it will save being charged in 2013/14 as well.

IVD Australia is pleased to see that many of the new inclusions ("IVD* and not human") are from member companies, however there are still a number of members who have not yet transitioned any products. Please let us know what we can do to help you with this important process - see below for one opportunity.

 Conformity Assessment Training - there are still places available in the IVD Australia Conformity Assessment Training to be held in Melbourne on 20th July - please register here if you wish to participate. This is an essential course for all members who are looking to have Class 3 or 4 ARTG inclusions in the next 12 months and was very well received when we ran it in Sydney. We are not anticipating running this training again until early 2013 so this will be the last opportunity this year.

IVD Australia Networking Meeting - we will be holding a Member Networking Meeting on July 26 in North Ryde. Peter will be presenting an Update for Members on all things IVDA and we will have guest speakers from On-Q Recruitment outlining the results from theier latest (2012) Salary and Job Satisfaction Survey. This will provide invaluable information on the salary and benefits trends in the health sector. Please register here for catering purposes.

 Point of Care Working Group (POCWG) - the newly formed Point-of-Care Working Group has met several times of the last month. The Group, which currently has 8 members, elected Martin Rocliffe of AMSL as Chair at its first meeting. It has drafted a Terms of Reference and at present it is focussing on facilitating a Clinical Workshop and Demonstration at the Australian College of Rural and Remote Medicine (ACRRM) Conference in Fremantle in October. Membership of the Working Group is open to all IVD Australia members who are interested in PoCT and the Working Group proceedings,

We are also encouraging members to participate in the ACRRM Workshop - you don't need to exhibit at ACRRM as IVD Australia will have a Booth. You just need to come to Fremantle for the Workshop and demonstrate your PoCT equipment over a 2 hour period. We are seeking about 6 -8 companies who have PoCT equipment to provide a "live" demonstration - similar to the APPN meeting 2 years ago. Please call / email to indicate your interest.

In-House Assay Working Group - was formed at a meeting in late May and currently has 4 members. The primary focus for this Group is the release of the draft NPAAC Standard on In-house assays which is due for release for public comment in early July (see below). Any members who wish to assist with the IVD Australia response should contact me via phone or email

 Pathology Services Table - IVD Australia has been invited to propose a nomination for the reformed Pathology Services Table Committee (PSTC).  The PSTC is the clinical expert committtee that both the Department and MSAC refer to regarding the addition/ removal of pathology items from the Medical Benefits Schedule. This invitation represents a significant achievement for IVD Australia and  confirms our standing within the Australia Pathology Sector and our level of recognition with the Department and the Minister for Health and Ageing.

The Board is currently considering a list of possible nominations for this important role. IVD Australia has been asked to nominate someone with expertise in the development of newer assays  and upcoming technologies as we move to the era of companion diagnostics and pharmacogenomics. If there is someone specifically who you know may fit this role, please contact Paul Cray or Nino Totino with your suggestions.

Parliamentary Secretary - I met with Hon. Catherine King MP and her Health Advisor in mid May. We covered a number of issuse including;

• IVD Transition and ARTG inclusions
• TGA Fees and Charges - see above
• Direct to Consumer IVDs - in light of FDA approval of Ora-sure HIV test
• In-house IVDs
• Codes of Conduct in the Health sector.

TGA National Manager - I met with the new TGA National Manager, Dr John Skerritt, who is an old acquaintance, in late May. I congratulated him on his appointment on behalf of IVD Australia members and we discussed a number of issues affecting members;

• TGA Fees and Charges - see above
• IVD Transition and Training for sponsors
• TGA Medical Device Reforms and the impact on IVDs
• TGA role in the regulation of in-house IVDs
• Third Party Conformity Assessment for Medical Devices and IVDs
• TGA Transparency

Members will be pleased to know that Dr Skerritt has a strong background in the development of immunoassays and has a good understanding of the requirement for the development and validation of IVDs

National Pathology Accreditation Advisory Committee (NPAAC) - is close to releasing it's 2012 redraft of the NPAAC Standard for in-house assays (as mentioned above). Once this has been released we will have a limited time to respond as it is anticipated that NPAAC will want to finalise the document at its October meeting.

NATA - has also started to formally acknowlege its role in the accreditation of laboratories to the NPAAC standard with a statement on its website outlning laboratories responsibilities in complying with the Standard. 

DAFF Biosecurity (AQIS) - are looking to finally undertake their Review of the importation of Lab Biologicals. We met with them in Canberra recently and one of the more pleasing suggestions was that they may consider use of a ranking system for imports and permits. This will mean that members who have a good track record of compliance and who are importing minimum risk biologicals will have less restrictive conditions on permits and faster clearance of shipments. It was also suggested that IVD Australia members could participate in the review of the Quarantine Act which is scheduled to take place over the next 12 months.

The Department of Agriculture, Fisheries & Forestry (DAFF) are conducting a  Stakeholder Survey which is now open.  You can access the survey by  clicking the link here . The survey will be open until midnight Friday 6 July 2012. You can also access the latest (June 2012) version of the Biosecurity Bulletin from the DAFF website

Members are also reminded that AQIS Fees and Charges have been frozen for the next 12 months so take advantage of this opportunity to renew permits early should they expire in mid 2013.

 Australian Point of Care Practictioners Network (APPN) - we were advised in late June by Rosy Tirimacco of APPN that the Federal Government funding for the APPN program would not be extended into 2012/13.  The program that Rosy has developed on behalf of APPN and AABB is a fantastic resource and it would be a great shame to see it not continue.

We have had discussions with AACB on this issue and understand that they are exploring a number of options to keep the APPN program operating, albeit at a somewhat reduced capacity. Certainly with the formation of the Point of Care Working Group, IVD Australia is looking to increase its participation in this area and we will continue discussion with AACB on how we can assist.

TGA Sponsor Training Day - was organised by the 5 Medical Device Associations and held on May 22nd at Old Parliament House, Canberra.  It was an outstanding success with over 250 registrants and a number  of people who could not be accommodated. The IVD sessions presented by Fiona MaCormick and Peter Kaylock were well attended and well received. Those that attended are reminded to complete the online survey so we can plan for a bigger and better event next year.

RCPA - have released their latest (June 2012) e-Pathway Newsletter which you can view here

National Serology Reference Laboratory (NRL) - Sponsors and Manufacturers that support the Annual NRL Workshop in Infectious Diseases play an integral role in ensuring the NRL Workshop’s success.  NRL would like to take the opportunity to thank you for your continued support and seek your feedback on how they (and we) can improve future NRL Workshops for Sponsors. Accordingly NRL invites you to join them for discussions over wine and cheese on Thursday, 02 August 2012, at 6pm at the NRL Meeting. To RSVP (20th July) or for further details please contact Thu-Anh Pham at NRL.

Finally, the IVD Australia office will be closed next week as both Glenda and I will be on vacation. However our phones and email will still be operating if there are any urgent matters.