Harry Jenkins (Scullin, Australian Labor Party) Share this | Hansard source

I will try to return to the bill. I was allowing myself to be provoked by the disorderly behaviour of others in the Main Committee, and I apologise. I thought that one should note the difference when it comes to these bills. To the officers of the department, the authority or whoever you are: I am not trying to belittle this bill; I am just making the comparison that sometimes we are allowed to have these full debates about minor matters whereas we have minor debates about the major matters. I think that is a little incongruous.

Others in this debate have illustrated—I think, because they have been assisted by the Bills Digestthe technicalities of the bill. I want to make the observation that this is an important area, whether it is to do with therapeutic goods or any other good. Australian manufacturers and Australian government authorities should look to ways of using information technology and assisting in the electronic transfer of information as efficiently as possible. I regret that on other occasions I have had to observe that, if there were a manufacturer in the electorate of Scullin who was involved in therapeutic goods and they were looking to take up the opportunities that this amendment will provide with regard to the process of gaining licences et cetera not in a written application but by way of electronic transfer, regrettably the broadband infrastructure in my electorate would probably not be sufficient that these manufacturers could compete. In that context, we note the decision of Telstra to suspend or to do away with their intention to roll out high-speed optical fibre broadband, which would have allowed, whether in this area or other areas, Australian manufacturers to maximise their efforts.

In many of the areas of therapeutic goods, we have allowed the manufacturers, in cooperation with the TGA, to set standards themselves. It is about a balance between the legislation regulation and what we see in other industries with self-determination practices and the like. Within the allowance of the standing orders, I want to draw attention to the front page of the Age of Monday of this week. The article is headed ‘Drug companies accused of manipulating trials’. When we have a piece of legislation like this bill before us, we have to be very careful in the area of therapeutic goods about the way we see the interconnect between the development, processing, licensing et cetera of the drug and then allowing it out into the market. This is one of the great challenges for government. The government has to use bodies like the TGA to carry this out. In the past, when it has come to therapeutic goods such as prescription drugs, the pharmaceutical companies have indicated that they believe that the processes that they have—particularly in the way they market—and the codes of conduct that they and the professions have are sufficient.

Why should this be a question that continues year in and year out? I was the chair of the House of Representatives Community Affairs committee back in the mid-nineties, when we did a major inquiry into, mainly, the Pharmaceutical Benefits Scheme, in which we went from manufacturing right through to the delivery of drugs to the consumer by the prescribing and dispensing practices of the professionals involved.

We have to have a flow of information that allows medical practitioners to be able to decide what drugs or therapeutic devices are appropriate and for the pharmacist to be able to give proper advice. In that, we rely on the pharmaceutical company representatives doing the right thing. The right thing is that, legitimately, they should ensure that those professionals are equipped with the information that enables them to be able to prescribe and dispense in a proper way and to give information to the consumer in a proper way. It is a form of ongoing education for those professionals. The problem is that there is a fine line; those practices can go beyond that information transfer into forms of incentive that move professionals to champion drugs only because of these incentives. That is why we have stories like this.

It is not just a problem that Australia confronts. Anybody who has read the Guardian Weekly, in the British context, over the last few months will have seen that it has been running similar stories. A lot of the manufacturers that gain licences for therapeutic goods under this act are multinational companies. This is a global phenomenon, and we cannot isolate ourselves from it in Australia. I think that is why we have to have a proper regime not only for the way in which we give manufacturing licences for medicinal products but also so that we can certify the audits of overseas medical manufacturers and things like that, which is the intention, in part, of this amendment to the main act. That is why it is very important that all practices in the process should be before us—not just the narrow band that this bill allows.

The main point that I wish to make is that the action being taken by the government by this amending legislation arises out of the audit report of December 2004. There is a suggestion that there are matters arising out of that report that may still need to be addressed, and that is of some importance. I welcome the opportunity to yet again speak on an amendment bill to the Therapeutic Goods Act. As I said, this may not be the most major bill that we have ever had before us, but it is important that Australia does have a regime of administering therapeutic goods that has its basis in safety and efficacy. They have been the issues that have always troubled legislators, because there are incidents where one has to decide: are these incidents just because of the actions of the manufacturer, or are they the result of us not being able to monitor and enforce the way in which the legislation operates? So, with those few remarks on this bill, I indicate my support for the legislation.

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