Melissa Parke (Fremantle, Australian Labor Party, Shadow Assistant Minister for Health) Share 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.

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