Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

I just wanted to make a few short comments on behalf of the opposition in relation to the matter of complementary medicines raised by both Senator Siewert and Senator Xenophon. The opposition did have discussions with the government because it was our understanding from the outset that this bill did not have any specific impact on complementary medicines. We just want to place on record that the government reassured us, in advice to the opposition, that the bill will have no specific impact on complementary medicines, that schedule 1 deals with scheduling of substances and is the subject of all the proposed amendments. The criteria for substances to be scheduled imply that there is some level of risk to their use. Complementary medicines are included on the Australian Register of Therapeutic Goods using the electronic listing facility, which involves a requirement that the substances in these medicines are low risk and hence not covered by scheduling. Furthermore, we were advised that there is no impact in the other schedules to the bill on complementary medicines beyond a minor change in schedule 3 to the rules around false advertising and medicine. Given those reassurances from the government, we just wanted to place on record that we do not share the concerns that were raised by Senators Siewert and Xenophon.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

I would like to move some amendments. The first amendment standing in my name is an amendment to schedule 1, item 7, which provides for consultation in relation to the development of regulations. I seek an amendment that requires, during the development of regulations for this framework, adequate and thorough consultation with all consumer health and therapeutic goods industry stakeholders, including representatives from the complementary medicines sector. As this proposed legislation will have an effect on the complementary medicines industry, it will only be appropriate that they have some involvement as to how the process will take place.

Russell Trood (Queensland, Liberal Party) Share this | Link to this | Hansard source

Senator Xenophon, do you wish to move these amendments together or separately?

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

If I may, I would like to move amendments (1), (2) and (3) together and amendment (4) separately.

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

Could I respectfully suggest that we discuss amendments (1) and (3) together and discuss amendment (2) separately because the Greens have a different position on amendments (1) and (3).

Russell Trood (Queensland, Liberal Party) Share this | Link to this | Hansard source

Is that acceptable, Senator Xenophon?

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

Since Senator Siewert asked me respectfully, I will accede to that. By leave—I move amendments (1) and (3) on sheet 5901 revised 2 together:

(1)    Schedule 1, item 7, page 4 (after line 15), after subsection 52A(2), insert:

        (3)    Before the Secretary makes a legislative instrument under subsection (2):

             (a)    the Secretary must ensure that adequate consultation has been undertaken with consumer health and therapeutic goods industry stakeholders; and

             (b)    having regard to that consultation, the Secretary must be satisfied that the proposed instrument will not have a negative impact on the therapeutic goods industry or on access by consumers to therapeutic goods.

        (4)    Before the Governor-General makes a regulation for the purposes of any provision in this Part:

             (a)    the Minister must ensure that adequate consultation has been undertaken with consumer health and therapeutic goods industry stakeholders; and

             (b)    having regard to that consultation, the Minister must be satisfied that the proposed regulation will not have a negative impact on the therapeutic goods industry or on access by consumers to therapeutic goods.

(3)    Schedule 1, item 12, page 7 (after line 32), at the end of section 52E, add:

        (6)    Before exercising a power under subsection 52D(2):

             (a)    the Secretary must ensure that adequate consultation has been undertaken with consumer health and therapeutic goods industry stakeholders; and

             (b)    having regard to that consultation, the Secretary must be satisfied that the proposed exercise of power will not have a negative impact on the therapeutic goods industry or on access by consumers to therapeutic goods.

I have already indicated what amendment (1) is about. Amendment (3) provides for appropriate consultation to occur in scheduling decisions. On the scheduling of complementary products, I seek a provision which will ensure appropriate and thorough consultation is conducted and that the complementary medicines industry is approached to participate in these discussions to provide their input and knowledge.

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

On behalf of the opposition I want to place on record that we share the observation put to us by the government that the whole point of scheduling is to impose restrictions on access to goods in the interests of public health and safety. The amendments moved by Senator Xenophon, requiring consultation and for the secretary to be satisfied that scheduling decisions will not have a negative impact on industry or access by consumers to therapeutic goods, might be an unachievable objective. As we said in our second reading comments, we very much urge the government to improve the quality of the consultation with industry and stakeholders. We do not believe that amendments (1) and (3) appropriately achieve that. By way of example, if new evidence emerged that a medicine currently available over the counter in pharmacies could be used as a precursor to an illicit drug, this provision—this is what the government has explained to us and we agree with this—would not allow the secretary to take action to restrict its availability by changing it to a prescription-only medicine. Such a change would adversely affect the industry and access by consumers. I understand where Senator Xenophon is coming from in moving the amendments and I understand the focus on appropriate consultation. However, we think that the amendments can have unintended and negative consequences and, as such, we will not be supporting them.

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

I find myself in the strange situation where I am agreeing with the opposition for the second time in a week.

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

Senator Cormann interjecting—

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

I know—the twilight zone twice in one week! The Greens also have issues with consultation, which I touched on earlier, particularly about feedback and the ongoing process of dialogue with industry and the sector. We think it needs to be improved. We have similar concerns with the amendments outlined by Senator Xenophon, where it says ‘the Secretary must be satisfied that the proposed instrument will not have a negative impact’. Unfortunately, it depends on how you view ‘negative impact’, but we also have to be aware—accepting Senator Cormann’s comments around possible illicit use of certain chemicals and drugs—that we are dealing with an extensive industry. There may be people who do not have the best intentions in providing a complementary medicine. We all know that false claims are made. If a decision were made, that could be seen as having a negative impact on the therapeutic goods industry. We have some concerns that that is a very broad statement. We understand the intent. The Greens are very concerned to ensure that complementary medicines are able to take their proper role in our healthcare system and are supported, but we think this is much too broad and may have an adverse impact on the industry rather than it being a positive approach. We applaud the intent but unfortunately cannot support the wording of the amendment.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

Subsection 52A simply provides that the secretary can expand the definition of a substance by legislative instrument to ensure that it can be subject to scheduling control. It has no regulatory impact unless a substance is then scheduled. Accordingly, there is no real need for consultation. Proposed new subsection (4), establishing a requirement for consultation on regulations, is superfluous and redundant. The Legislative Instruments Act 2003 mandates appropriate consultation with affected parties.

Amendment (3) is also redundant as part of the rescheduling process requires interested parties to be given the opportunity to make a submission to the relevant expert advisory committee. It is also against the very basis of the act to require the secretary to be satisfied that scheduling decisions will not have a negative impact on the industry or access by consumers to therapeutic goods. The whole point of scheduling is to impose restrictions on access to goods in the interests of public health and safety. Under these amendments, the secretary would never be able to make a decision to schedule previously unscheduled substances or up-schedule existing scheduled substances. For example, if evidence emerged that a medicine currently available over the counter in pharmacies could be used as a precursor to an illicit drug, this provision would not allow the secretary to take action to restrict its availability by changing it to a prescription-only medicine as such a change would adversely affect the industry and access by consumers. It was recognised in the Galbally review that these scheduling controls can have negative impacts on industry but are needed for the protection of public health and safety.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

I thank my colleagues for their indication as to where they stand in relation to these particular amendments. Could the minister advise, though, on the level of consultation that will take place in relation to scheduling in terms of an overall framework? Could he give me further details on what that will be? There is a concern amongst the complementary healthcare industry and professionals that there has been a lack of input. He has alluded to the fact that there will be a degree of consultation. If he could briefly outline what that will be, that would be quite useful. I will not be seeking a division. I do not think there is any point in seeking to divide in relation to these amendments, given that I am the last one standing in relation to it.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

I am advised that we consulted for about a month on the scheduling process, which is the core of these changes, but we have also indicated that we are going out for another month or so later in the year on from the draft regulations. So we are being quite open to those consultations before and we have given a commitment to do so into the future.

Question negatived.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

I move amendment (2) on sheet 5901 revised 2:

(2)    Schedule 1, item 8, page 4 (after line 25), after subsection 52B(3), insert:

     (3A)    The regulations must provide:

             (a)    for the Minister to appoint to the Committee a person with expertise in complementary medicines; and

             (b)    for that person to be a member of the Committee only for the purpose of the committee undertaking functions in relation to substances which are, or which contain, complementary medicines.

      (3B)    In this section:

complementary medicines has the same meaning it has in Part 6-4.

This amendment provides for committee membership to include a person of expertise in complementary medicines. This amendment provides for inclusion on the Advisory Medicines Scheduling Committee of a person with expertise in complementary medicines specifically during the scheduling of products which contain complementary medicine products. Public safety is absolutely paramount and greater awareness and consultation can only assist to ensure that the appropriate knowledge and background is gained in deciding the scheduling of these products.

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

On behalf of the opposition, while we agree that people with appropriate expertise should be appointed to the various committees, we do not think it is actually a very good proposition to identify various, dare I say, interested parties to give them a guaranteed seat at the table. People should be identified based on their expertise and it should not be seen as representative of a particular lobby group representing a particular industry interest. Furthermore, given that there is only a very, very minor relevance of this scheduling process as far as complementary medicines are concerned, if one were to pick out a particular industry vested interest, the opposition cannot really see why we should single out complementary medicines in particular, given that they are not actually covered by scheduling, as I mentioned in my opening remarks in the committee stage.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

Members will be appointed to the two new committees on the basis of their expertise and not their representative affiliations. The scheduling policy framework endorsed by government already makes provision for each committee to include a member with expertise in industry matters. The inclusion of a member with expertise from each sector of the therapeutic goods industry would attract criticism from other groups with an interest in scheduling and an expectation that additional seats would be offered to them. The committee would be totally unworkable under these circumstances.

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

This is an amendment that the Greens do support, which is why I asked for it to be separated from amendments (1) and (3). I note—and Senator Xenophon, I am sure, will make this point too—that the amendment says ‘with expertise in complementary medicines’; it does not say ‘a representative of the complementary medicines industry’. It is in the same way that you have expertise in more traditional—‘traditional’ is not the right word—

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

Conventional.

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

conventional, that is the right word, medicine. So this is not actually a representative. The Greens felt that this was an appropriate approach to ensuring that the issues around complementary medicines are included in decision making. Complementary medicines are increasingly becoming part of our healthcare system, as we have been discussing during this debate. So we felt that in fact it was an appropriate approach. The amendment is very clear about it not being a representative; it describes somebody with expertise. Somebody can have expertise in complementary medicine and in fact not be part of the industry or part of a particular commercial approach, if that is what both the government and the opposition are implying. They are implying that somebody may have a vested interest in complementary medicine. There are a lot of people with expertise in complementary medicines who in fact would not be a part of the commercial sector. We thought it was a valid approach and we will be supporting the amendment.

Question negatived.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

I hope it is a case of fourth time lucky. I move amendment (4) standing in my name:

(4)    Schedule 1, page 9 (after line 16), at the end of the Schedule, add:

14  At the end of Part 6-3

Add:

52EC  Review of scheduling regime

        (1)    The Minister must cause an independent review of the operation of this Part to be conducted, with particular reference to the amendments to this Part made by the Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (the amendments).

        (2)    The review must:

             (a)    start not later than 1 July 2013; and

             (b)    be completed within 6 months.

        (3)    The review must report on:

             (a)    the system of access controls for goods containing scheduled substances established by this Part;

             (b)    the outcomes of the administration of scheduled substances by the Secretary and by the committees established by this Part;

             (c)    the effect of the amendments on the therapeutic goods industry and on individual parties within the industry;

             (d)    whether there are adequate avenues for review of decisions made by the Secretary and by the committees established by this Part;

and may make recommendations for further changes to the scheduling regime.

        (4)    The review must be conducted by a panel which must comprise not less than three, and not more than five, persons with relevant expertise, including a person with expertise in complementary medicines.

        (5)    As part of the review, the panel must invite and consider public submissions.

        (6)    The panel must give the Minister a written report of the review.

        (7)    The Minister must cause a copy of the report to be laid before each House of the Parliament within 15 sitting days of that House after the day on which the Minister receives the report.

This amendment relates to a review of the scheduling regime. It provides for review in 2013, three years after the proposed legislation takes effect. This review must be completed within six months and must be conducted by a panel which comprises no fewer than three and no more than five persons with relevant expertise, including a person with expertise in complementary medicines. As Senator Siewert pointed out in relation to the previous amendment, it does not have to include an industry representative; it is just someone who has an expertise in complementary medicines. This will ensure a thorough, open and adequate review. The panel must invite and consider public submissions. The panel must report on the provision of access controls for goods containing scheduled substances, the outcome of administration of scheduled substances, the effect of the amendments on the therapeutic goods industry, and whether there are adequate avenues for review of decisions.

I have had some very useful discussions with both the government and the opposition. I did take on board the feedback from the government that there ought to be six months to complete the review rather than three months, as I initially indicated, and I think that is a good suggestion, and also that there be some flexibility in the number of people that should be part of the committee—between three and five. I think it gives enough flexibility. But it is also important that there ought to be someone with some expertise in complementary medicines to be part of this review. That could be one of three or one of four or five. It is important that that be raised given the concerns of the complementary medicines industry, which is a significant industry that millions of Australians access each year.

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

The opposition have had some very good discussions with Senator Xenophon and we are of a mind to support this amendment. There have been some discussions with both the government and Senator Xenophon about the exact terms of this amendment. We are nearly there, but there has been a last-minute addition in proposed paragraph 52EC(4), which had not previously been circulated to us given the time frames involved. These are the words ‘including a person with expertise in complementary medicines’ to be included on the review panel once it takes place after 1 July 2013.

The opposition support the review because we think it is important. However, we do not believe it is appropriate to single out one particular area of expertise above others. We urge the government, in their comments in this chamber as we are debating this, to give some assurances as to how they will ensure that there is a proper balance of expertise on this particular committee. Through you, Mr Temporary Chairman, I indicate to Senator Xenophon that the opposition would like to support this amendment. However, we will have difficulty in supporting it if it continues to contain a specific requirement to include a person with expertise in complementary medicines—something that we were not aware of until it was circulated this morning.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

The proposal is inconsistent with the report of the Senate Community Affairs Legislation Committee, which examined this bill and recommended that the bill be passed without amendment. The government does not consider the separate scheduling arrangements of medicines and chemicals to be implemented by this bill to be a major change. All they do is provide for the secretary rather than a statutory authority to be the decision maker and divide the current single committee into two expert advisory committees. However, given that these changes will not come into effect until the best part of a decade after the review by Mr Galbally, the government accepts that there may be merit in a further review of the scheme after it has been in operation for some time. However, there is no real case for the review panel to be required to include a person with expertise in complementary medicines. The overwhelming majority of the substances that are scheduled are prescription medicines or over-the-counter medicines. Complementary medicines are low risk and do not meet the criteria for scheduling. Therefore, I move an amendment to Senator Xenophon’s amendment (4):

Omit from Paragraph (4):

the words “including a person with expertise in complementary medicines”

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

I indicate on behalf of the opposition that we support the government’s amendment.

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

I indicate that the Greens support Senator Xenophon’s amendment. We would prefer to retain the reference to complementary medicine, but I can see that we are going to go down in a screaming heap, so we will not call a division. But, as I said, we support the original amendment proposed by Senator Xenophon and we just put on record the fact that we would prefer to retain the reference to a person with expertise. We are talking about someone with expertise, not somebody from the industry or a representative. We would prefer to keep that in.

Russell Trood (Queensland, Liberal Party) Share this | Link to this | Hansard source

It may not be as severe a defeat as you think, Senator Siewert.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

Ditto in relation to what Senator Siewert has said. Would the minister indicate what level of consultation there would be to ensure that the complementary medicines industry does have a say in this process. If there is not a specific person with that expertise, will there be people who have a broad range of expertise both in pharmaceutical and complementary medicines in the context of this? I have had some private discussions with the parliamentary secretary and the minister’s office in relation to this, but it would be very useful if that could be elaborated on for the record.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

I am advised that the consultations will include submissions, which I am sure will be from the complementary medicines sector. We envisage that there will be a chair with legal expertise, public health expertise and wide industry experience, not just expertise in the complementary sector.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

Senator Xenophon interjecting—

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

But not including a direct representative.

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

Someone with expertise.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

Yes, somebody with expertise across the broad range—I am advised.

Mathias Cormann (WA, Liberal Party, Shadow Parliamentary Secretary for Health Administration) Share this | Link to this | Hansard source

Including complementary.

Stephen Conroy (Victoria, Australian Labor Party, Deputy Leader of the Government in the Senate) Share this | Link to this | Hansard source

Including complementary, but not a direct representative. That is the difference, which I think we are all happy with.

Nick Xenophon (SA, Independent) Share this | Link to this | Hansard source

That will do, Mr Temporary Chairman. Thank you.

Russell Trood (Queensland, Liberal Party) Share this | Link to this | Hansard source

You are merciful; thank you. The question is that the amendment proposed by Senator Conroy to Senator Xenophon’s amendment (4) on sheet 5901 revised be agreed to.

Question agreed to.

Original question, as amended, agreed to.

Bill, as amended, agreed to.

Bill reported with an amendment; report adopted.