IVD Australia launches

IVD Australia has been launched at the Australasian Association of Clinical Biochemists (AACB) Annual Scientific Conference at the Brisbane Convention and Exhibition Centre.

IVD Australia is the recently formed Association representing companies that manufacture and supply in-vitro diagnostics in Australia. In-vitro diagnostics (IVDs) comprises the instruments and reagents that are used to perform pathology tests requested by general practitioners or specialist physicians. These are generally performed in accredited public and private pathology laboratories across Australia, but IVD’s also include over-the-counter tests such as blood glucose meters for diabetes testing and home pregnancy test kits. Supply of these products is regulated for the Government by the Therapeutic Goods Administration (TGA).

IVD Australia represents multinational companies and local distributors as well as Australian manufacturers of IVD’s. IVD Australia members currently supply products valued at over $650,000,000 and they employ 1550 people across Australia.

In launching IVD Australia, Board Chairman, Adrian Tennyenhuis of Vital Diagnostics indicated that there were a number of issues facing the IVD sector at the present time. These included the imminent introduction of the IVD Framework which would result in IVDs being regulated by the TGA in the same manner as medical devices. This would incorporate a four-year transition period to enable products that are currently exempt from listing on the Australian Register of Therapeutic Goods (ARTG) to be included under the new framework.

“Whilst the IVD sector is supportive of the new IVD Framework and continues to work cooperatively with the TGA to implement these major changes, IVD Australia is concerned that the cost of regulation will mean a reduction in the availability of critical diagnostics in some areas,” said Tennyenhuis. “It is likely that companies will decide not to transition important low-turnover products at the end of the four-year period rather than face the expense of inclusion on the ARTG.”

Other major issues facing the sector, highlighted at the launch, include the push for the adoption of a universal code of conduct, the abandonment of the pathology MOU by the Rudd government earlier this year and the emergence of personalised medicine, with its emphasis on diagnostics in conjunction with other health technologies such as targeted pharmaceuticals.

Dr Peter Harmanis the Chief Executive Officer and he can be contacted by email at p.harman@ivd.org.au.