House debates

Wednesday, 19 August 2009

Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009

Second Reading

12:16 pm

Photo of Jill HallJill Hall (Shortland, Australian Labor Party) Share this | Hansard source

I must say that I wholeheartedly agree with the comments that the member for Mallee made about consultation. In regards to consultation on the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009, there has been extensive consultation over a very long period of time about the new scheduling arrangements, particularly in relation to medicines. There has been consultation—and I am sure he will be really happy to hear this—with the Department of Agriculture, Fisheries and Forestry, the Australian Pesticides and Veterinary Medicines Authority and Safe Work Australia. They are all bodies that I am sure he would like the government to consult with.

The most recent consultations occurred in May this year on the key documents that underpin the new arrangements. I also reassure the member for Mallee that the Rudd government is totally and absolutely committed to consultation in all areas, particularly in relation to health. I just refer him to the current consultation that is taking place under the reforming Australian health care agenda. I encourage him to consult with his community and to consult with the government about that because it is all part of the overall health care agenda for this country; ensuring that his constituents and the constituents of every member of this House gets quality health care, just as this Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 actually refers to another very important part of our health agenda.

Quite often these pieces of legislation relating to therapeutic goods slip through the parliament without people taking too much notice of them, but I have to say that each and every one of them adds to a different aspect of our health system and is vitally important. They actually streamline the way our health system works. They make our health system safe. They also ensure that the medicines, chemicals, appliances and various other products that the Therapeutic Goods Act 1989 applies to are actually going to benefit all Australians. They also ensure that they are appropriate.

This bill amends the Therapeutic Goods Act 1989. It implements new, separate scheduling arrangements for medicines and chemicals. It enables the Secretary of the Department of Health and Ageing—as we all know, the department responsible for therapeutic goods—to declare the purpose for which particular kinds of medical devices cannot be included in the Australian Register of Therapeutic Goods and thus made available. That is a very important aspect of this legislation.

The bill extends the circumstances in which consultation can occur with the Gene Technology Regulator on therapeutic goods that are or that contain genetically modified organisms, in addition to genetically modified products currently provided for under the act. I am sure the member for Mallee, given his commitment to the need for greater and ongoing consultation in this area, would also welcome this aspect of the bill that extends consultation; it is actually encouraging consultation with the organisations and authorities that he is particularly keen to see consulted.

The bill also amends the advertising offence provisions so that it is offence for any person to advertise a therapeutic good inappropriately, for a purpose that has not been accepted in relation to that product. In the past, I have had reason to be concerned about this particular area and I took a matter to the TGA. I have always found them very receptive. I have also taken this issue to state bodies because one case was contravening quite a few things. Once again, this simple provision shows how important these amendments to the Therapeutic Goods Act are and how important it is for every member to be mindful of legislation as it comes through.

The bill amends the delegation provisions to enable regulations to specify a relevant person for the purposes of exercising delegation under section 19A of the act. That is pretty self-explanatory. It helps make the legislation work, because you need to have someone who can exercise that delegation; otherwise, the whole system becomes unworkable.

Finally, the bill introduces provisions to enable the minister, by legislative instrument, to specify advisory statements that are required to be included on the labels of specified medicines. Once again, that is an extremely important amendment. I believe manufacturers of medicines are beholden to highlight what is in a certain product, and that should be on the label. That gives the consumer the ability to decide whether or not it is appropriate for them to take that medicine, as such labelling will flag whether there is an ingredient in that medicine that a consumer might be allergic to.

It is important to note there are further amendments planned for later in the year to establish a new framework for the regulation of human cellular and tissue based therapy products, and to make additional improvements to the regulation of therapeutic goods in Australia and the operation of the act. Once again, I emphasise that this will be done in close consultation with all sectors of the community—all interested parties.

It is vitally important that we support these changes to the Therapeutic Goods Act. I must thank the opposition, too, for giving its wholehearted support to these changes. They know, as we know, that changes like these are ensuring greater safety for the Australian community and keeping the act up to date.

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