New in vitro diagnostic regulations legislated

The new IVD Regulations, which have been in negotiation with the industry for over seven years, have finally become legislation with their publication on the Federal Register on March 3.

“These Regulations will totally change the way in vitro diagnostics (IVDs) 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.

The IVD Regulatory Framework, as it has become known, was first conceived in 2003 when the TGA, in consultation with industry, proposed a new regulatory framework that was “harmonised with world best practice” to complement the revised medical device framework that was to be introduced in October 2002. In October 2003, following consultation with stakeholders, the Australian Health Minister’s Conference (AHMC) agreed in principle to the introduction of the proposed framework, including the regulation of laboratory developed (also known as in-house or home-brew) assays. In April 2004, AHMC endorsed the Regulatory Impact Statement, and the TGA commenced drafting of the necessary changes to the Medical Device regulations.

The changes were, however, significantly delayed by the failed implementation of the combined Australian and New Zealand Therapeutic Products Authority (ANZTPA), and serious negotiation did not recommence until the beginning of 2009. Since that time, with the formation of IVD Australia in July 2009, a great deal of negotiation has taken place on the details of the regulations.

The new regulations, which come into force on 1 July 2010, are intended to provide the mechanism for the regulation of all in vitro diagnostic devices supplied in Australia. Until now, only a very limited range of IVDs have required pre-market regulatory approval and inclusion on the Australian Register of Therapeutic Goods (ARTG). Under the new regulatory scheme, which consists of amendments to the existing Medical Device Regulations, all new IVDs will be required to be included on the ARTG before they can be supplied in Australia. Products currently supplied in Australia will have a 4-year transition period to enable sponsors and manufacturers to make application for their inclusion onto the ARTG.

The regulatory framework is based on the Global Harmonisation Task Force (GHTF) model and is quite different to the current European and US systems. IVDs will be classified into four classes based on assessed personal and public health risk, with the highest-risk products being included in Class 4 and lower-risk products in Classes 3, 2 and 1. The assignment of products by manufacturers into a particular risk Class will be based on a series of classification rules which are written into the Regulations.

A number of products will still remain exempt from inclusion; these include products used solely for workplace or home drugs of abuse and alcohol testing, genetic tests for the determination of parentage or relationship, as well as IVDs used exclusively for veterinary purposes. These products are not considered to be 'therapeutic goods' and will not be regulated by the TGA. However, drugs-of-abuse assays which have a therapeutic intended use will not be exempt and will be subject to regulation by the TGA. In addition, the supply of home use tests for notifiable infectious diseases, cancer makers, myocardial infarction or genetic disorders will not be permitted under the new Regulations.

Despite having agreed with the TGA on the commencement date of the Regulations, IVD Australia remains concerned at a number of aspects of the new framework.

“We believe there will be a dramatic increase in the cost of regulation. 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. 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,” said Dr Harman.

“In addition, IVD Australia is also very concerned that the cost of regulation, both direct and indirect, will cause sponsors to reassess the importation of some products. In the case of some assays, the direct cost to include a single product on the ARTG is likely to exceed $40,000 and hence, whilst existing products may continue to be supplied during the transition period, IVD Australia is convinced there will a significant number of products that will not be transitioned by June 2014, even allowing for the application of the TGA Low Volume/ Low Value business rules.”

Dr Harman also commented that “Australia is the first jurisdiction to attempt to fully implement the GHTF framework for IVDs. However, given that the usage of IVDs in Australia represents less than 2% of the global market, much of the documentation that will be required by the TGA will not be available at present in the GHTF format, leading to further costs for manufacturers and sponsors.

“IVD Australia would like, however, to commend the TGA and the Office of Devices, Blood and Tissues on the spirit of cooperation and willingness to discuss and negotiate on the issues that arose through this lengthy process. 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,” said Harman.

IVD Australia is the Industry Association representing companies that manufacture and supply in vitro diagnostics in Australia. In vitro (literally 'in glass') diagnostics (IVDs) comprise 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 IVDs also include over-the-counter tests such as blood glucose meters for diabetes testing and home pregnancy test kits.