IVD legislation goes live amidst industry concern

The in vitro diagnostics (IVD) industry has expressed concerns over some aspects of the new IVD legislation that has now officially passed into law.

The legislation, called the Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 1), puts into place new regulations covering the manufacture and sale of in vitro diagnostic devices which conforms to the guidelines put in place by the Global Harmonization Task Force (GHTF), an international body aiming to standardise medical regulations around the world.

The legislation classifies IVDs into four categories based on personal and public health risks. Some devices, such as workplace drug and alcohol tests, are excluded from the regulation, and others, such as genetic self-tests are banned outright.

IVD Australia, the industry body representing manufacturers and suppliers of IVDs, has expressed concerns that the legislation will add to the complexity of releasing an IVD and will increase the cost of IVDs.

"These Regulations will totally change the way in vitro diagnostics in Australia are regulated, and whilst the industry is broadly supportive of the changes, concerns remain however regarding the costs to industry and the likelihood that a number of older but important diagnostic tests will not be transitioned onto the new Framework," said Peter Harman, IVD Australia chief executive officer, in a statement.

IVD Australia has expressed concerns that the increased complexity of the regulations will require many IVD manufacturers to put on additional specialised staff in order to comply with the new legislation. This, in turn, will increase the cost of IVDs.

"The TGA’s own estimate is that the cost over the first five years of the new Regulations will be in the order of $16 million dollars," said Harman. "IVD Australia believes however that the direct cost to sponsors and manufacturers will exceed $25 million. In addition most Australian sponsors and manufacturers will require additional staff and expertise to enable them to collect the documentation and make the necessary applications.”

Others, such as Arthur Brandwood, principal of regulatory consulting firm, Brandwood Biomedical, have suggested that some international manufacturers might decide against releasing their IVD products in Australia, or Australian IVD manufacturers might focus on international markets before releasing their products here.

Even with its concerns over the legislation, IVD Australia has expressed that the industry will embrace the new regulations.

"IVD Australia would like however to commend the TGA and the Office of Devices, Blood and Tissues on the spirit of co-operation and willingness to discuss and negotiate on the issues that arose through this lengthy process," said Harman. "Whilst we have not agreed on all aspects of the new Regulations, we have been able to reach a position that provides a framework that industry can work with going forward."

The new legislation will come into effect on July 1, 2010.