Stephen Parry (Tasmania, Liberal Party) Share this | Link to this | Hansard source

The opposition understands that the Greens have an amendment, which I have indicated to Senator Siewert we will be opposing. The Parliamentary Secretary to the Minister for Health and Ageing, in her speech in the second reading debate, answered the opposition’s questions. As indicated in the second reading debate, we will support the bill but oppose the Greens’ amendment.

Rachel Siewert (WA, Australian Greens) Share this | Link to this | Hansard source

Thank you, Senator Parry, for clarifying that before I had even moved my amendment! I move Greens amendment (1) on sheet 5767:

(1)    Schedule 1, item 2, page 4 (after line 29), after section 41GS, insert:

41GSA  Parliamentary committee scrutiny of exemption notices

        (1)    As soon as practicable after the commencement of the first session of each Parliament a standing committee of each House of the Parliament is to be nominated, according to the practice of the relevant House, as its nominated committee for the purposes of this section.

        (2)    As soon as practicable after 30 June and 31 December each year the Minister must cause a document setting out the particulars of:

             (a)    all exemptions under section 41GS; and

             (b)    all variations and revocations under section 41GU;

in the previous six-month period to be provided to the nominated committee of each House of the Parliament.

        (3)    Each nominated committee is to receive each document provided in accordance with subsection (2) on a confidential basis.

        (4)    Each committee, and each member of each committee, must treat the information contained in any such document as confidential, and must not publish any part of that information to any other person except as authorised by this section.

        (5)    The committee may refer to the information contained in any such document and any conclusions drawn from it in a report to either House of the Parliament, but must not disclose the information in such a report.

I apologise for not being in the chamber to speak on this earlier; I was otherwise detained. The Greens overall are supportive of the purposes of the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009]. The broad intent of the bill is to minimise regulatory obligations while maintaining appropriate levels of scrutiny and accountability, which are so vitally important when dealing with the products which come under the jurisdiction of this act. We believe there are obvious merits in the provisions that increase transparency of the processes of the Therapeutic Goods Administration and provide public access to a range of information held by the TGA. Similarly, the Greens support the changes to the fit and proper person test for manufacturing licensees and distributors, which will improve objectivity for administrative purposes. We appreciate the provision to include additional default standards for submissions to the TGA; adding the American and European pharmacopoeias to the British pharmacopoeia as default standards will provide greater flexibility to the pharmaceutical industry, with significant benefits that will flow on to Australian consumers.

The provisions to strengthen penalties for breaches of the act are appropriate and should be supported. Furthermore, it is important to state that the Greens appreciate and support the primary purpose of the bill: to allow for the stockpiling of medical devices and pharmaceutical medicines in case of a threat to public health and possible future emergency. To do this, this bill introduces provisions which will exempt medical devices from certain requirements for inclusion in the Australian Register of Therapeutic Goods in line with the amendment made to the act in 2002 for other therapeutic goods, including pharmaceutical medicines.

We do not dispute that there may be a case for fast-tracking in certain cases and for the process to ensure public health; however, what concerns us about this bill is that it takes this process one step further away from the processes of transparency and accountability which currently exist. It removes the requirement for exemption instruments to be disallowable—that is, the exemptions will no longer be subject to any parliamentary or public scrutiny and this entire process will be determined by the minister. This is the issue which creates concerns for the Greens, which is why I am moving this amendment.

This bill would give the minister discretionary power to exempt medical devices from key requirements, including those relating to the obligations of manufacturers of medical devices in relation to conformity assessment procedures, medical devices, clarifications and conformity assessment certificates, and the listing in the Australian Register of Therapeutic Goods. There are very sound reasons for the requirements for registration in the Australian Register of Therapeutic Goods. Before a product can be marketed in Australia it must have achieved regulatory approval and be registered. This involves the TGA assessing the quality, safety and efficacy of the product. The transparency of this process is an essential part of ensuring high standards of safety and public confidence. Knowledge that a product is registered on the ARTG provides certainty to all Australians that the processes have been thorough and rigorous. Exempting certain therapeutic goods from this register—that is, those that the minister determines to be required for stockpiling in certain circumstances—creates a degree of risk in this process. The risk may not be great, but the question remains whether there is sufficient justification for introducing any degree of risk at all.

We are very concerned. The most worrying part of this bill for us is the provision under clause 41GS(6), which states that these emergency exemptions would not be a legislative instrument, thereby exempting them from the usual tabling and disallowance regime under the Legislative Instruments Act. The bill also changes this requirement for pharmaceuticals under these circumstances. Since the amendment made to the act in 2002, pharmaceuticals deemed necessary for stockpiling in these circumstances have been subject to parliamentary scrutiny by legislative instrument. The changes proposed in this bill will enable emergency exemptions for therapeutic goods to be completely removed from parliamentary scrutiny and disallowance. Additionally, notices prohibiting advertisements containing misleading and false representations, and ministerial orders relating to the non-applicability of standards in particular circumstances, will not be legislative instruments under this bill.

We are also deeply concerned about the issues around ministerial discretion. Under clause 41GS(2) the minister can exercise that discretion if he or she is satisfied that it would be ‘in the national interest’ for the exemption to be made to deal with (a) a possible threat to public health or (b) an actual threat to public health. However, the definitional parameters of these terms are not specified, and it is not clear how or on what basis determinations about a potential threat to public health or possible future emergencies would be made. We believe there are significant issues around emergency stockpiling. We are deeply concerned there will no longer be any public scrutiny of purchases because of that particular clause in the act.

We have looked at this bill very thoroughly. We do appreciate why there needs to be these powers, but we are deeply concerned that they will not be subject any longer to the process of a regulatory instrument. We believe there does need to be some scrutiny, so we have proposed a process whereby a parliamentary committee could in fact scrutinise the exemption notices. There are similar circumstances where this occurs. It would not be done publicly, it would conform with the taking away of the legislative instrument process, but it would enable a form of scrutiny. As the bill stands now, there will be no oversight of that. We will no longer be able to check what is on those lists. We will not know what the minister and the government have purchased for those lists. What will the level of scrutiny be to ensure that we are in fact preparing adequately, or that the pharmaceuticals or the medical devices purchased are the appropriate and proper pharmaceuticals or medical devices?

This amendment is designed to allow a level of scrutiny while still allowing for the information not to be made public. We are concerned about always using the issue of bio-threats to justify decision making and secrecy. We do understand, though, that there may be instances where we do not want some of the pharmaceuticals and medical devices purchased in the pubic arena, so we believe this is an appropriate compromise to ensure a level of scrutiny by a parliamentary committee—in a confidential process, I might add. We therefore commend the Greens amendment to the chamber.

Ursula Stephens (NSW, Australian Labor Party, Parliamentary Secretary Assisting the Prime Minister for Social Inclusion) Share this | Link to this | Hansard source

Can I indicate to Senator Siewert in fairness that the government does not support the amendment. Firstly, we need to remember that these exemptions are not legislative instruments and never ought to have been disallowable. They do not state the law generally or modify the law generally; they are really in the nature of permits, and permits are not as a rule visible to parliament, far less subject to parliamentary scrutiny or disallowance. Currently under section 19 of the act the secretary may approve the importation of unregistered medicines for use in clinical trials or for the treatment of particular individuals. Under section 19 the secretary may approve the importation of unregistered medicines to replace medicines that are on the register but in short supply, as long as a person has applied to have the replacement medicine registered in Australia or they have been registered in another country. These approvals, which result in the immediate supply of unregistered medicines to people in Australia, are not appropriately subject to any parliamentary reporting or oversight.

Secondly, the government has been advised that these exemptions should be kept confidential for reasons of national security. Making them available automatically to a committee of each house will unnecessarily broaden the number of people who will have access to the information without any countervailing benefit.

Thirdly, Senator Siewert’s amendment does not seem to be very workable, especially as far as proposed subsection (5) is concerned. I do not see how a committee could refer to information about exemptions in a report to parliament without actually revealing the substance of those exemptions, and I do not see how useful that could be.

Finally, establishing a committee of each house for this purpose with biannual reporting could be a very heavy-handed approach given that most of the time there would be nothing to report. So, while I understand the principle you are pursuing, its application in the circumstances is inappropriate.

Rachel Siewert (WA, Australian Greens) Share this | Link to this | Hansard source

I am aware of the time constraints so I will be brief. The concern around national security is in fact the point. Pulling out the national security card to justify excluding scrutiny of this process is of concern to the Greens. However, I understand that I am not going to get very far in this argument, so I will simply put my amendment.

Cory Bernardi (SA, Liberal Party) Share this | Link to this | Hansard source

The question is that Greens amendment (1) on sheet 5767 be agreed to.

Question negatived.

Bill agreed to.

Bill reported; report adopted.