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

For the benefit of the member for Blair, the first fax machines in the world were developed in the late 1870s. They did not become a world standard. It took us about another 100 years before they became world standard very simply because there was a particular way of going about it. If you go back to about 1986, when I attempted to convince Voca Communications that it would be really smart to provide scanners to electorate offices by simply upping the dpi from 200 to 300 in the fax machines that they were providing us—it was possible to make a technological leap—Voca were able to supply the Department of Finance and Administration with fax machines at the time simply because there were worldwide standards.

In the 1870s the first fax machines were put into place. The problem was that you had to have one fax machine from one manufacturer at one end and another fax machine at the other end that was exactly the same. But it was in the late 19th century that the first images passed from one end of the globe to the other by fax. The Japanese realised that you did not have to have a piece of paper to put an application in that had to be handed mechanically to someone. Because of the nature of the currency system that they have, you could write what you wanted and then send it electronically by fax machine, because it was a facsimile.

In this legislation finally we get a realisation that it does not have to be on a bit of paper. You can send it. You can write it and then send it by fax. Legally you can do that in almost any transaction or contract in Australia and that is allowed. But we go a bit further, and in this legislation it says not just sending it by fax but sending a representation of what you originally did on paper. You can lodge it on an e-business basis. To get from there to here over time takes quite a great deal. People do this in halting steps. The government has been right, as have other governments around the world, that it is possible to do things better and to be assured that you can improve, in this case, licensing for medicines, blood products and tissue by making this change to facilitate it. If you set up your system in the right way you can be assured that people from outside are not participating in this process, as long as you get the right protocols, it is signed off and it is not people who are trying to subvert the system. You can do it in a more efficient way.

If you look at the broader question of how we move goods around and the controls there are in Quarantine, Customs and so on, there has been a slow and deliberate process of changing over to these kinds of mechanisms. So people involved in shipping, companies that are heavily involved in goods forwarding and so on realised many years ago that it was a hell of a lot smarter to do it this way than it was to use the old paper forms. Even though we have a GST that is still fundamentally designed the same way as the GST was in the 1960s—and it was introduced in Europe and elsewhere as a paper based trail—you can in fact do all of that electronically. It is a case of: if you can do it, why wouldn’t you? In terms of the operations of the act, this simple amendment:

... will remove the requirement for an application for a manufacturing licence to be made in writing, and instead permit the electronic lodgement of an application. The amendments will make section 37 consistent with other provisions in the Act.

Departments have all sorts of problems. Often they have problems with their ministers, with the people who work for them and with their systems. When there is a proposal to change the mode of work, there can be resistance from people within the department or simply due to the amount of time and effort it takes to make the changes. But it can be that sometimes there is a big impetus to get these things under way.

If you look at the work that the library has done on the Therapeutic Goods Amendment Bill (No. 3) 2006, you can see that in the relevant department there was a bit of both here. There was some internal movement. They decided to bring in what was called a ‘manufacturer information system’ to provide for more efficient processing of the different types of applications made to the various areas of the TGA. The purpose of that, they outlined, was to eliminate paper forms and to allow electronic application for manufacturing licences for medicinal natural products, certification by audit of overseas medicines manufacturers, variations to each of the above and clearance certification of overseas medicines and manufacturers by assessment of GMP evidence provided by an overseas regulatory body.

That process is fairly broad ranging. It looks like a simple thing here to say that it does not have to be on a bit of paper—even a bit of paper that can be lodged by fax—and that you can go to an electronic system. Anyone who has tried to introduce a system like this knows that it is not as simple as it might seem. It involves a great deal of reorganisation of the department. People who have done similar things at universities in trying to deal with new personnel systems and so on know that what used to be simple becomes more complex, particularly when you are dealing with a whole range of different manufacturers. Also, you have to educate people in how to use these systems, particularly if you have people using them overseas, but the benefits are clear and significant.

If you can get everybody used to the new system, not only can you be quicker but you can be smarter. You can also track what has been done in a much more efficient way than previously. An example of what happens can be seen in this parliament with its move to using less paper. We still push out volumes of the stuff and overutilise it. We have photocopiers all over the place, including in our offices. The great idea—and this may even be taken as part of it—was that we would go to a paperless office. But people think we are using more paper than we did in the past. However, there is some light ahead—and the Deputy Speaker would agree with me on this—in terms of the amount of paper that is being pushed out because, at the practical level, departments are pushing to do this sort of thing and are making those sorts of changes. There is also some light ahead because of the capacity of current computers to churn through images and because we have a bigger and broader storage capacity than we had before. We have better scanners. We are trialling a program in the electorate offices that uses networked photocopiers, which we hope will work.

We should be able to use those photocopiers as scanners, which I tried to get Voca to do in 1986. If they were used with Nuance software—which has changed its name to PaperPort—which is almost the industry standard, you could do away with most of the paperwork. Not only could you image your material and store it but you could use optical character recognition, which is now of a fairly high standard. You could make fully searchable electronic documents not only in electorate offices but also in Parliament House. The Parliamentary Library has done that.

If you want to know about the therapeutic goods amendment bill 2003, it is available in electronic form. The Bills Digest is also available in that form from the library. Any material associated with this, including press releases in which people in the industry have made comment on this or any other bill, is imaged and made into a searchable, portable document format. That means you can have a greater control over what is happening, and for people in therapeutic goods it means you can have efficiencies in running the department and dealing with the mass of paper documentation because, having made it into an electronic business system, it is searchable and more available to you. The Bills Digest sums up the benefits in this way:

The benefits associated with the electronic lodgement of manufacturing licence applications were highlighted in the second reading speech of the Bill; in particular, that the amendments will allow manufacturer’s to monitor progress with their licence applications and electronically submit requests for amendments to their licences.

I note that, even though this came out of the library, they were not able to use an apostrophe in the way that they should have. It is in fact not ‘manufacturer’s’ but the plural. One day we might march through.

The Australian National Audit Office in October 2004 brought down their report Regulation of non-prescription medicinal products. They were concerned about the whole process that had been undertaken under the Therapeutic Goods Act. The Bills Digest reads:

The audit report was critical of the information management systems and processes employed by the TGA, including its data management, documentation and recordkeeping procedures, and recommended that these systems be improved.

It is argued that, on this change we are giving legislative effect to, the message already got through to the Therapeutic Goods Administration and they brought in this system because of the investigation that the audit office had undertaken. So they have incorporated that. In the Department of Health and Ageing’s response to the audit they argued that many of the issues raised by the ANAO were being addressed and that they planned activities to address all the audit recommendations, but none had been fully implemented at that time. The challenges to a department in trying to deal with a world that is changing and with seemingly simple changes of this nature are fairly big, particularly where you are not just dealing with medicines. We have seen recent major changes in the government’s introduction of new regulations and new approaches to medicines that have gone off the protected patented areas. We have gone into generics with a major piece of legislation I spoke about in this chamber some time ago.

Trying to facilitate—for both directly Australian owned and offshore multinationals in Australia, such as Pfizer and so on—the licensing of those products and streamlining them will be beneficial in terms of the major pharmaceutical area, but there are also the fundamental issues of blood, blood products, tissues and their trade within Australia and world wide. There has been a significant attempt by the Red Cross and the authorities that are still responsible for this in Australia to boost Australian participation in donating blood and to boost the attempt to make people understand that, if you are one of the one in 10 or so people who is going to do it, you should support it and give it as much of a run as you can.

The alternative, if Australians do not do it in the numbers they have done it in historically, is that we will end up with blood products and tissue products coming in from overseas. They will add to our current account problems. They will also add to the question of whether or not those products have been effectively dealt with in terms of disease control and so on. The responsible Australian authorities in this regard are not afraid to change the licensing system to go to an e-business system, but I think they would be grateful to those members who in the past have dealt with the issues of the collection of Australian blood, its storage, the challenges in public health issues associated with our control of this. They would also be grateful that people freely and voluntarily have decided to help others in the community, that we do not trade blood as a good as other countries do and that it is one of the foundation stones of the way we see ourselves. In that area I think the most important things are (1) keeping local control, (2) ensuring that the voluntarism innate in our system is maintained and (3) that people get the message that it is very important that they join in and try to ensure this is the case.

Broadly, this change has been a simple one legislatively, if not simple at the level of the organisation that has had to deal with it. It has made a response not only to the Australian National Audit Office but to pressures within the department itself to make those changes. But the story is that 10 years on from 1996, with a government that is all about auditing and benchmarking, you have to make some practical changes to give effect to the government’s e-business strategy. I applaud the fact that in this regard it has done that. The Bills Digest says at the end:

According to the government, the amendments proposed in the Bill are expected to facilitate the speedy submission of licence applications from manufacturers and the efficient handling of these applications by the TGA. The amendments address the audit report recommendations that the TGA improve the integration of its information management systems, and strengthen its documentation procedures.

The final sentence, however, raises an issue generally but it is one that I put directly to the responsible minister or parliamentary secretary in terms of dealing with this at the end of the debate. It says:

However, in light of the Deloitte’s report, Parliament may want to confirm that implementation of all the ANAO’s recommendations has materially progressed since June 2005.

So I would put that specific issue posed by the Parliamentary Library to the relevant minister, parliamentary secretary or whoever is dealing with this at the end. However slight this bill is in terms of the legislative change that is made, the actual application here goes to something broader and deeper. So you either front up and do what the ANAO say, wherever they are housed, or you only go part way to making the sorts of changes that can really make a dramatic and significant effect and haul Australia kicking and screaming into an electronically image based world—a world in which e-business is not only possible but certified by the government taking the lead in its implementations. It needs to ensure that not only in relation to the Therapeutic Goods Act and all that it entails but across all government departments the move towards e-business is facilitated and that the mechanical needs of computer capacity and imaging are available across all sites. I point out to those in the National Party and the Liberal Party who want to abolish my seat of Blaxland, arguing that regionally people have been affected badly, you can access an electorate office by fax or image. (Time expired)

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