Melissa Parke (Fremantle, Australian Labor Party, Shadow Assistant Minister for Health) Share this | Link to this | Hansard source

I move:

(1) Page 40 (after line 12), after Schedule 15, insert:

Schedule 15A—Public notification and recovery

Therapeutic Goods Act 1989

1 After paragraph 30EA(2)(b)

  Insert:

  (ba) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

     (i) therapeutic goods;

     (ii) the circumstances referred to in paragraph (1)(a) in relation to therapeutic goods;

2 At the end of subsection 30EA(2)

  Add:

  ; (d) to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom therapeutic goods have been supplied.

3 After paragraph 32HA(2)(b)

  Insert:

  (ba) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

     (i) the biological;

     (ii) the circumstances referred to in paragraph (1)(a);

4 At the end of subsection 32HA(2)

  Add:

  ; (d) to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom the biological has been supplied.

5 Subsection 41KA(2)

  Omit "one or both", substitute "one or more".

6 At the end of subsection 41KA(2)

  Add:

  ; (c) to inform the public or a specified class of persons, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to either or both of the following:

     (i) medical devices of that kind;

     (ii) the circumstances referred to in paragraph (1)(a);

(d) to publish, in the specified manner and within such reasonable period as is specified, specified information, or information of a specified kind, relating to the manufacture or distribution of medical devices of that kind;

  (e) to notify the Secretary, in the specified manner and within such reasonable period as is specified, of specified information, or of information of a specified kind, relating to the persons to whom medical devices of that kind have been supplied.

7 Application of amendments

  Therapeutic goods

(1) The amendments of section 30EA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item, whether the therapeutic goods to which the requirement relates are registered or listed before or after that commencement.

  Biologicals

(2) The amendments of section 32HA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item, whether the biological to which the requirement relates is included in the Register before or after that commencement.

  Medical devices

(3) The amendments of section 41KA of the Therapeutic Goods Act 1989 made by this Schedule apply in relation to requirements imposed on or after the commencement of this item, whether the kind of medical device to which the requirement relates is included in the Register before or after that commencement.

As I suggested in my prior remarks, the amendment includes some straightforward but significant changes to the sections within the notification and recovery part of the Therapeutic Goods Act. They are changes the substance which will be no surprise to the government and which are not hard to understand. These changes formed part of the bill as listed during the 43rd parliament and represent an important beneficial change to the scope of the TGA's oversight and protective function. The proposed amendments expand that scope in relation to three categories, namely, therapeutic goods; biologicals, which means a product involving human cells or human tissue; and, finally, medical devices. The proposed amendments will enable the secretary to not only require a sponsor of these products to give notification of a certain event—for example, the deregistration of a product—but also to give more explanation regarding the circumstances of that event. In the case of medical devices, the proposed amendment adds the capacity to require publication of specified information, a capacity that already exists in relation to therapeutic goods and biologicals. Most importantly of all, the proposed amendment will enable the secretary of the department to require from the sponsor of a therapeutic good, biological or medical device the details of those who have received or been treated with a particular product. This is an important improvement to the way we deal with issues that arise in relation to health products, and it is a reform that I hope the government is prepared to reconsider.

There have been cases in the past where ineffective medicines or defective medical implants have affected thousands of Australians, and, needless to say, in such circumstances it is vital that all those affected receive appropriate information and advice as a matter of urgency. In 2010 and 2011 we confronted the fact that more than 5,000 Australians had received a faulty hip transplant involving a metal-on-metal device produced by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. This has caused pain, ill-health and severe anxiety for people who received those implants, and involved painful and complicated surgery to remedy—and for some it has not been remedied and perhaps never will be. Some patients also now suffer severe cobalt and chromium blood poisoning for which there is apparently no cure.

We have seen other examples, in Australia and elsewhere, involving breast implants that had been supplied, in some cases over a 10-year period, before problems were discovered. Only a few years ago, a French manufacturer of breast implants was forced to admit that it had fraudulently substituted a form of silicon in its implants that was different to the compound that had been assessed and approved for that purpose. This raised questions not only for the women involved but also for their children who might be affected through breastfeeding.

While I am informed that manufacturers and suppliers of pharmaceuticals and medical devices in Australia are usually cooperative with the TGA, these situations I have given examples of are precisely the kinds of circumstances where you must have absolutely no doubt regarding the strong and clear regulatory capacity of the TGA to compel the sponsors and suppliers of health products to give appropriate notification, and notification that includes the relevant circumstances.

What is more, it is essential we have the regulatory capacity to require the details of those affected so that the imperative of ensuring that Australian health consumers are contacted and informed about issues that could have a serious impact on their health is not left in the hands of the product sponsors alone. I do understand that the word 'regulation' has negative associations as far as this government is concerned, but I think the government should think long and hard about the community's expectations when it comes to proper safeguards, transparency and oversight in the health space.

The amendment I have moved does not add a compliance or regulatory burden in the ordinary course of things. What the amendment will achieve—as it was designed to do in consultation with the TGA, the health department and the wider health-care sector during the 43rd Parliament—is a stronger and clearer set of mechanisms to make sure that, when a problem arises with the quality, efficacy or, most importantly, safety of a health product, the Australian community and the Australian men, women and children affected can be properly informed and assisted in a timely way.

As I have said, it is difficult to understand why the amendments I am now moving, and which were contained in the previous version of the bill, have been cut out. I can only assume that a slightly over-zealous cutting crew has taken the snip to these provisions in the name of a broad anti-red-tape crusade without sufficient regard to the public health impact. I would urge this government to accept this amendment to their version of this bill, which the opposition is otherwise very happy to support.

Peter Dutton (Dickson, Liberal Party, Minister for Health) Share this | Link to this | Hansard source

Can I start by thanking the member for Fremantle for her contribution. I know that she is sincere in her approach to what is a very serious issue, particularly for those patients whom she quite rightly identified as having had difficulty around implants or other issues, and the government is very sensitive to those particular issues and keen to try to strike a balance.

But we do believe that the opposition has gone too far in terms of that which they seek from the amendments to sections 30EA, 32HA and 41KA of the Therapeutic Goods Act. The government does not believe that the amendments are necessary and believes that they do have the definite potential to add to regulatory burden in the absence of a demonstrated need.

By way of background, the TGA can mandate the recall of therapeutic goods in particular circumstances. For instance, if the product does not comply with applicable standards, the product is supplied without approval—that is, when it is not included in the Australian Register of Therapeutic Goods, as required, or when the safety, quality or efficacy of the goods is unacceptable. The TGA can currently cancel products from the register where there are safety issues. The sponsor of the product can then no longer supply the product. The sections that were proposed to be amended relate to the TGA's powers to take action to recall products already in the market and to provide information to the public about those products. In circumstances where the TGA can, under existing provisions, mandate a recall, the TGA can currently require the sponsor of the goods to provide to the public information that those circumstances—for example, the quality of the goods is unacceptable—exist. Moreover, the TGA can, in the case of medicines or biologicals, require the sponsor to publish information about the manufacture or supply of those goods. The amendments would have allowed the TGA to require the sponsor to provide to the public directly more information about the circumstances giving rise to a right to recall—for example, a cancellation—and to provide to the TGA information about persons to whom the goods have been supplied.

The removal of these amendments does not represent a risk to the public. The TGA can already require a sponsor to provide information about the safety of a product in matters relating to supply. The TGA can also publish information on its website about the safe use of therapeutic goods and other regulatory decisions made under the act, such as decisions to cancel a product from the register. The TGA is also able to provide information to health-care professionals about the status of therapeutic goods and their safe use. The amendments would have meant that this information could be required to be published by the sponsor or provided by the sponsor directly to a class of persons, such as health-care professionals. In other words, the effect of the amendments was to require the sponsor, rather than the TGA, to make this information available. The government does not believe that, in the absence of a demonstrated need, statutory obligations should be placed on industry. The government is, of course, at liberty to revisit this matter should circumstances change.

There are no restrictions on the TGA publishing such information on its website, which is where the public of course may expect to find it. The TGA now provides comprehensive information on its website about all recalls of therapeutic goods. It also publishes information in the form of hazard alerts about medical devices in relation to which safety issues have arisen. The amendments were not prompted by any particular practical issues experienced by the TGA with sponsors not volunteering information about persons to whom products had been supplied.

I will finish on this final note, which goes not to the member for Fremantle's contribution but to the position of the opposition when in government, because their significant record—perhaps their most outstanding record from a Labor perspective—is that they introduced almost 21,000 regulations but only repealed 104.

It is the case that under Labor, business was burdened with new taxes and regulations without due consideration of the impact. The coalition's priority is to build a stronger more productive and diverse economy through more efficient government and more productive businesses that will deliver more jobs, higher wages and better services for all Australians. The government's deregulation agenda is absolutely central to this cause. On that basis we oppose the amendments.

Bruce Scott (Maranoa, Deputy-Speaker) Share this | Link to this | Hansard source

The question is that the amendments be agreed to. There being more than one voice calling for a division, in accordance with standing order 133 the division is deferred until after 8 pm.

Debate adjourned.