Feature: Regulatory headache for IVDs

Australia’s biotechnology industry is no stranger to pioneering new technologies and approaches. But soon the entire Australian medical diagnostics industry will be acting as an international guinea pig for a new regulatory model for in vitro diagnostic (IVD) medical devices. This time, however, being first isn’t necessarily a good thing.

The new regulations are intended to set some boundaries for an area of the industry that has been largely exempt from regulation in the past. In shaping the regulations, the Therapeutic Goods Administration (TGA) has sought guidance from the Global Harmonization Task Force (GHTF), which is the international body aiming to standardise medical regulations around the world. This might appear to be a sensible attempt to steer the Australian regulations towards some kind of international standard, except for one thing, says consultant and veteran of the regulatory industry, Susan Alder.

“The TGA says they’re harmonised with the GHTF, but the problem with that is no other country has adopted the GHTF. So you haven’t harmonised with another country, you’ve harmonised with a standard no-one’s adopted.” The upshot of that is a regulatory model for IVDs that is uniquely Australian – which effectively puts Australia out of step with other countries.

In addition to being unique, the TGA’s proposed legislation is substantially more complex than that fielded in other regions. “I’ve worked in regulatory for 30 years,” says Alder, “and this system is way more complicated than medical devices. It’s going to be very complicated for inexperienced companies to get their heads around.” There’s also a concern that IVD regulation may be going too far. “The TGA is really not used to dealing with these products,” says Alder. “The industry’s concern is that when the TGA is not hugely experienced, they tend to over-regulate.”

Arthur Brandwood, principal of regulatory consulting firm, Brandwood Biomedical, suggests that this could have ramifications for Australian biotechs. “The issue is that the proposed model is very contentious. It’s applying a lot of regulatory oversight to what some regard as low risk products.” And with more regulation comes a higher cost of compliance. “It’s questionable whether some sectors of the industry will be able to bear the cost of the level of regulation that’s been proposed.”

The proposed legislation itself classifies IVDs into four categories based on personal and public health risks. The lowest segment, Class 1, includes items with low private and public risk, such as reagents, receptacles and microbiological culture media – as well IVDs intended for export only. These will be the easiest to manage, as manufacturers will simply be required to self-declare that their products conform to the essential principles of the regulations and submit an application to the TGA for their IVD to appear on the Australian Register of Therapeutic Goods (ARTG).

Class 2 IVDs include things like pregnancy tests and other tests that aren’t the sole determinant for diagnosis of a disease. Manufacturers must also be able to prove their devices function as intended as well as conform to manufacturing standards.

Class 3 IVDs include any tests for infectious diseases, tests that could put an individual in danger if it gives an erroneous reading and tests that represent the sole determinant for a diagnosis. The regulatory requirements for Class 3 are similar to Class 2, except for a subset of devices for which the TGA will perform a more thorough assessment of the manufacturer’s supplied documentation.

Class 4 includes high risk tests, including those that screen for transmissible agents in blood, such as HIV and hepatitis tests. For this Class, the TGA will actually carry out performance testing in addition to the requirements for Class 3 IVDs.

Some self-tests for genetic disorders, infectious diseases and life threatening diseases like cancer will be banned outright. Although that won’t prevent individuals from purchasing said tests over the internet from vendors, scrupulous or miscreant.

In order to handle their regulatory requirements, manufacturers of IVDs will have to seriously consider seeking out expertise in the area – a task that may prove challenging in itself, says Alder. “A lot of companies don’t have staff who are used to dealing with regulatory issues and dealing with the bureaucracy of the TGA. It’s a huge added expense, in both staff and the cost of the actual regulatory process, which for many companies – particularly small Australian biotech companies – will be considerable.”

Brandwood’s advice is to rethink whether the Australian market is even worth the effort. His tip for IVD manufacturers: “identify your international markets and go for those.” Then, once regulatory approval is found overseas, that may make gaining approval here easier down the track.

Whatever approach is taken, Alder cautions manufacturers to get their head around the regulations sooner rather than later. “There’s a level of complacency that has come in to the IVD industry in Australia that this has been delayed for so long that we’ll forget about it until it comes.” Yes, there is a four year transition period from the passing of the legislation, but that doesn’t mean manufacturers should wait until the last moment to become compliant. “There’s a real need for the industry to start taking this seriously.”

This feature appeared in the September/October 2009 issue of Australian Life Scientist. To subscribe to the magazine, go here.