Michael Hatton (Blaxland, Australian Labor Party) Share this | Hansard source

We have had a broad-ranging debate so far on the Therapeutic Goods Amendment Bill (No. 3) 2006, based on what is fundamentally a very minor change. The amendment to the Therapeutic Goods Act in this bill allows those manufacturers of medicines, blood and tissues to make an application for a manufacturing licence electronically using the Therapeutic Goods Administration’s e-business system. That brings it into line not only with a number of other government departments which are using e-business but also with changes that have already occurred.

I want to look at a couple of aspects of this. One is the broad question of e-business and the transition from the old paper forms across government to the new electronic model. The other is the effectiveness within the department itself and the fact that the manner in which the particular matters were carried out by the department has been heavily criticised. In the background paper put together by the Parliamentary Library, there is a section—which I will deal with a bit later—with regard to an audit report done by the Australian National Audit Office on the manner in which the department had been conducting itself.

This is a tiny example of a change, but the implications are very great. The old system—one could say almost a 19th century approach but a very useful one, people just simply being able to write—specifically stated this, and that is why we actually require a specific change. That is section 37(1) of the Therapeutic Goods Act 1989. It says:

(1)

An application for a licence must:

(a)

be made in writing in accordance with a form approved by the Secretary ...

You can find that in just about any government documentation you can imagine. But specifically under the Therapeutic Goods Act in order to get the licence it had to be in writing and it had to be on the right form. The change here is to say that it does not have to be in writing on a bit of paper. It can be in text form and certified text form as part of the process being introduced in e-business, and that is as good as you will get. This would be of no surprise to the Japanese, who worked it out a very long time ago. The original fax machines were developed in the 19th century and used to transport a paper written piece of work. The first fax machines were not developed in Japan but the Japanese took them up more than anyone else.

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