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

On behalf of the opposition I will make a reasonably short contribution to indicate that the opposition supports the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009 as a non-controversial bill. Our attitude to this bill is similar to previous TGA bills we debated in recent times. It continues the reforms which were commenced under the Howard government and which were delayed by the withdrawal of New Zealand from the development of a joint regulatory arrangement in 2007.

We support the ongoing streamlining and improvement of the regulatory processes surrounding the TGA, which is of course one of the important pillars of our healthcare system. There has been general support for the principles underlying this bill; however, there has been some significant concern—and this has been a consistent theme coming through in relation to these TGA bills—about the lack of quality in terms of the consultation processes. We really do urge the government to take heed of this. We know that they have given some assurances that there will be further and ongoing consultation as these measures are implemented.

This bill will do a number of things. It will separate the scheduling of medicines from the scheduling of poisons. It will give the secretary of the health department the power to preclude certain uses for medical devices on the Australian Register of Therapeutic Goods. There is a series of other amendments, which include provisions for greater consultation with the Gene Technology Regulator on genetically modified organisms and various changes to offence provisions. And, of course, there are some provisions empowering the Minister for Health and Ageing to specify advisory statements on specific medicines.

The opposition flags that we have had discussions with Senator Xenophon, who has circulated a series of amendments. We will not be supporting the amendments in relation to consultation and changes to the medicines scheduling committee. However, the opposition will be supporting a proposal to conduct a review of the operation of this bill at a time to be specified in Senator Xenophon’s amendment. So, as I said before, we consider this to be largely a very non-controversial bill. It is part of ongoing reforms that have been taking place for some time. We urge the government to make a serious effort to improve the quality of the consultation that takes place around measures like this. That is an issue that was also picked up by the Senate community affairs committee in their report. So, with those few remarks I indicate the opposition’s support for this bill. (Quorum formed)

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

The Australian Greens agree in principle to the Therapeutic Goods Amendment (2009 Measures No. 2) Bill 2009, which amends the Therapeutic Goods Act of 1989. The issue of separating scheduling arrangements for medicines and chemicals is something that goes back, as we understand it, to 2001, when the Australian Health Ministers Conference commissioned the Galbally review. Then we had an advisory committee working group in 2003. In 2007 we saw the abandonment of the Australia-New Zealand transnational authority. Now, some eight years later, we have an Australia-only initiative.

Australia’s natural healthcare industry is worth billions of dollars and we need to make sure that we have appropriate regulation in place. More than 70 per cent of Australians under 35 use complementary healthcare products and a quarter of the population visit complementary healthcare practitioners each year. Consumers increasingly demand greater choice when it comes to healthcare and they are increasingly seeking better quality of the products and assurances of safety.

Complementary healthcare products have an important role to play in our preventative healthcare approach to maintaining healthier lives by combining traditional and alternative therapies within healthcare programs. The Greens are very supportive of this approach. This has resulted in the wide use of supplements, traditional remedies and other natural healthcare products. The Australian natural healthcare industry is integrated into our national health system. There are more than 17,000 products—including vitamins, minerals and herbs, as well as aromatherapy and homeopathic supplements. These contain around 2,200 active ingredients that are listed by the Australian government’s industry regulator, the Therapeutic Goods Administration—or, as it is commonly known, the TGA. The natural healthcare industry is no longer just the preserve of small, independent stakeholders. It is a growing industry with big business involvement and, as I said earlier, it is worth billions of dollars around the globe.

The Therapeutic Goods Amendment Bill proposes to change arrangements for the scheduling of medicines and chemicals. It gives more discretionary power to the Secretary of the Department of Health and Ageing to declare the purpose for which particular kinds of medical devices cannot be included in the Australian Register of Therapeutic Goods. Purposes will be precluded where such a use would pose a risk to public health or where it would otherwise be inappropriate. The Productivity Commission has advised that these new arrangements should be implemented as soon as possible. These arrangements will provide greater clarity and opportunity for individuals to make applications to the department to seek amendment to the scheduling of a substance. The secretary will be able to seek advice from a member of the committee or from another person, such as a recognised international expert, if that will be useful. This is important and will need to be monitored to address concerns that have been raised by stakeholders about identifying expertise when it comes to understanding complementary medicines. We need to make sure that this is implemented effectively.

A Senate inquiry into the bill was conducted by the Community Affairs Legislation Committee over a relatively short period of time. Nonetheless, it was effective in delivering useful advice from the community and from experts on this legislation. The report called on the Minister for Health and Ageing, Minister Roxon, and her department:

… to work constructively together through a number of areas where industry raised concerns, and which will be the subject of legislative instruments, including membership and expertise on the Scheduling Committees, chemicals scheduling, appeal and review of decisions by the Secretary, cost recovery and the publication of advisory statements.

The Greens share the concerns of Senator Xenophon—and I know he will speak shortly—and support some of the amendments he has circulated. Particularly, we think it is important to have an independent review because, as I said, the community raises concerns about these issues and there should be a process to make sure that the changes are proving effective and efficient.

The Greens have consistently called for more transparency in advertising. We believe that the health industry needs to provide more reliable information around safety, efficiency and effectiveness. Consumers need to feel they can trust what they are being told about health products—that is, whether they are the more commercial and traditional medicines or complementary medicines. The health reform agenda has identified a key role for personal responsibility and the government needs to play its part to ensure that standards are set for the evidence for health product claims being presented to consumers.

The Community Affairs Legislation Committee heard from all sectors of the industry that had raised issues with the Department of Health and Ageing about their approach to consultation. It was not that there had been a lack of consultation; rather it was that it lacked meaningful feedback to explain why decisions had been reached and whether their proposals had been considered and rejected or simply ignored. The process of consultation had improved considerably, but stakeholders still felt that there was not adequate feedback. Stakeholders emphasised their willingness to engage and work with the department to ensure the best possible outcomes not just for these scheduling arrangements but for the regulation of therapeutic products, medicines and chemicals in general. I must say I was pleasantly surprised at the inquiry, where people were genuinely supportive of these amendments. There were some concerns raised, which I am articulating now, but they were in general fairly supportive of these arrangements and sought to—rather than oppose—seek clarification and amendment. Given that there has been consultation, I think it is good process to provide feedback on the reasons decisions were made. People may still disagree with those decisions, but at least they will have an understanding of where the government is coming from. We believe this will enhance cooperation between the industry, stakeholders and the government.

Currently, Australia has a variety of complex and convoluted coregulatory systems to control unethical therapeutic claims and promotional practices depending upon the type of product and the media in which claims are made. It can be confusing. There are different standards and gross inconsistencies between various codes of conduct, complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness. This bill goes some way to clarifying what is meant by inappropriate advertising of therapeutic goods to ensure that appropriate, consistent and accurate information is provided to the public. It also improves transparency around the requirements for advisory statements on medicine labels by empowering the minister to specify them in a legislative instrument. These statements will assist consumers in choosing the most appropriate medicines and using them safely and effectively, as the medicines these statements apply to are generally those that individuals choose themselves or choose with some assistance from a pharmacist. It is particularly important that these statements are made, because then the medicines can be used effectively. When you use prescription medicines, a medical practitioner tells you how to use the them. I acknowledge that people do not always use them in the way that has been prescribed, but there is some advice. When you select them yourself, it is an individual choice so you need to be provided with adequate information with which to make choices.

This bill avoids the need for new state and territory legislation, and the Greens welcome this. The creation of a separate legislative approach to underpin chemicals scheduling would entail significant delays in achieving a separation of chemicals scheduling from medicines scheduling. Both medicines and chemicals committees would be responsible for amending the same legislative instrument, the Poisons Standard. The Greens acknowledge the difficulties this would present, with two acts having responsibility and control over the same instrument. This issue was raised during the Senate inquiry.

However, the arrangements put in place for the scheduling of chemicals should be seen, we believe, as interim steps that are subject to review after two years, as recommended by the Productivity Commission in its 2008 chemicals and plastics regulation research project. These interim measures should eventually be replaced by more appropriate federally controlled arrangements outside the control of the Therapeutic Goods Administration.

The Greens support the conclusion in the report of the Senate Standing Committee on Community Affairs that the government should commit to further consultation with the industry in ‘a renewed sprit of openness and cooperation that will provide meaningful feedback … to ensure that the new system … is totally transparent and accountable’. Simply put, we believe health risk should be reduced and that this legislation improves public health outcomes for the nation as a whole and provides an appropriate form of regulation for complementary medicines, subject to the comments we have made. We are pleased to see the approach that has been taken on this. There are still some issues that we think need to be dealt with in the future but it is certainly a step in the right direction.

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

When people think of medicine they may think of a chemist or a prescription. This debate might benefit from considering a broader definition of medicine, because the reality is the Australian people already do. Two-thirds of Australia’s adult population use at least one complementary medicine product each year and more than $2 billion is spent on complementary medicines annually. Yet, despite its increasing acceptance and use, the debate between conventional and complementary healthcare options continues amongst both experts and members of the public.

Personally, I see an acupuncturist as often as I see a medically trained doctor, and I visit my chemist for herbal supplements at the same time that I pick up my prescriptions. There is no question that public health and safety is paramount and that the regulation of all products and substances is crucial to ensure the health of all consumers. That must always be the fundamental, non-negotiable benchmark. No-one is questioning the need for appropriate scrutiny of health products, but should we be overregulating an industry to the extent that we cause it economic harm?

On the whole, complementary medicines stakeholders are supportive of theTherapeutic Goods Amendment (2009 Measures No. 2) Bill 2009. The Complementary Healthcare Council of Australia says that these amendments are long overdue and commends the government for progressing such changes. Similarly, the Australian Self Medication Industry says that the bill represents some important progress and offers its support. Among its measures, this bill will see two separate committees: one for the scheduling for medicines and one for poisons. It will require advisory statements to be included on labelling, where needed, to inform consumers and to raise awareness about the products. That is, of course, welcomed. These are positive changes to the legislation which will ensure the health and safety of the public. I commend the government for introducing these changes.

However, there remain concerns across the board about the lack of consultation that has taken place in the development of this bill and also the Therapeutic Goods Amendment (2009 Measures No. 1) Bill 2009, which was passed three weeks ago and to which I also spoke. It is fair to say that the complementary healthcare industry is worried about what consultation will or will not take place moving forward, given their concerns of exclusion so far. I understand that the measures of this bill will not commence until mid next year and that certain regulations and guidelines, particularly in regard to the advisory committee process, will be developed by the end of this year.

It is during the development of these regulations that representatives from the complementary medicines industry should be guaranteed adequate and thorough consultation for two reasons. Firstly, knowledge of complementary medicinal practices is very specific. Alan Stubenrauch, the federal vice president of the Complementary Medical Association, wrote a letter to me in which he said, ‘Matters as complex and unique as complementary medicines do need the attention of people who are well versed and informed in their uses, benefits and contraindications.’ Secondly, the proposed amendments affect their industry and it seems only fair that they are allowed to have an input into these changes. It is also disappointing to hear from the Complementary Healthcare Council that, despite the promise to them of an independent review of the industry as a whole before changes were to be made, legislation is being put forward on what they consider to be a piecemeal basis and without any discussion as to what it might mean for the complementary medicines industry in the long term. Having said that, I have been grateful and pleased with the discussions I have had with the government, particularly with Mr Butler, who has the carriage of this in the other place, and his office. It has been a very useful exercise and I have taken some comfort from that, but I think the concerns of the complementary health industry are valid and need to be addressed.

As such, I will be moving amendments to this bill which will require guaranteed consultation with industry stakeholders during the development of the regulations around the new advisory committee on medicine scheduling later this year. Another issue that has been brought to my attention by concerned members of the complementary medicines industry is that there remains no provision for representation on the advisory committee. While I appreciate that the experts assigned to these committees are experts in science—and it is entirely appropriate that they are on the committee—it would also be logical and fair that someone with expertise in the field traditional medicine is also given a role on the committee, particularly when determining the scheduling of complementary medicine substances.

In its submission to the Senate committee, the Complementary Healthcare Council stated:

Complementary medicines have various paradigms, (e.g. differing uses and methods of manufacturing) and these should be taken into consideration when assessing and evaluating such substances.

As I have already stated, two-thirds of Australian adults consume or partake in some form of alternative therapy or complementary medicine each year. We need to address the opportunity that complementary medicine providers have for decisions to be reviewed by an independent body. Under the proposed changes the TGA secretary will, upon the advice of the advisory committee, make a decision about the scheduling of a substance and/or product. The Managing Director of Regulatory Solutions Pty Ltd, Doug Kentwell, understands that ‘the decision to amend a scheduling will rest with an officer of the Therapeutic Goods Administration, who can either accept, reject or vary a recommendation of the advisory committee’.

When I met with Mr Kentwell recently, he expressed his concern that, regardless of what the advisory committee decides, the decision ultimately will rest with a single member of the TGA. Following this, should a decision be contested, it is referred back to the TGA for review by a second person who was not involved in the initial decision-making process. The fact remains that the decision rests within the TGA. This concerns those who work in the complementary medicines industry, who feel that their case that is not always heard and that their concerns are not always listened to. There is no doubt that public health and safety is absolutely paramount, but, at the same time, we must be conscious not to restrict an alternative by putting regulations on industry that could seriously affect its viability without in any way advancing the fundamental issue of health and safety.

Val Johanson, Principal Consultant of Johanson and Associates Consulting and a former executive director of the Complementary Healthcare Council, writes:

The original intent of the regulation of natural health care products in Australia was to provide a risk based system of control over the safety and quality of these products—a light touch approach that reflects their very low risk. The ongoing evolution and implementation of the Australian regulatory system has resulted in an industry that is hamstrung and hobbled by inappropriate and excessive regulation and escalating costs and a market that lacks innovation and precludes consumers from freedom of choice for their own health care and access to new, effective low-risk products.

The emphasis there is on risk—that there must not be any risk to consumers in the context of this, or with any medicines. But it is important that there is not unnecessary regulation that does not advance the issue of public health and safety but merely hamstrings an industry unnecessarily, without good reason. Freedom of choice combined with assurances of safety is what it comes down to—providing Australians with safe health options from both conventional and other sources.

I believe it is crucial that we address the concerns not only of stakeholders from conventional medicine but of representatives from organisations like the Complementary Healthcare Council and the Complementary Medicine Association and persons such as Doug Kentwell and Val Johanson in the development of these new regulations. I will be seeking an amendment that requires independent review of these changes within three years of the proposed bill coming into effect and requires that that panel make recommendations for further changes to the scheduling regime so that we have in place a fair approach to complementary medicines.

I support this bill that the government has put forward. I commend the government on introducing positive changes which will further enhance and ensure public health and safety, but I do hope the government will be open to engaging stakeholders in appropriate consultation and to ongoing review of these changes to ensure that scheduling and regulation of complementary medicines is appropriate and fairly conducted.

Finally, I would like to commend the work of the committee, including Senator Siewert, who I think provided a very useful report in the context of looking at these changes. I think that has advanced the debate in a very positive way.

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

I thank all of those who have participated in the debate. As mentioned in the second reading speech, this bill amends the Therapeutic Goods Act 1989 in a number of ways. Most importantly, it implements new arrangements for the separate scheduling of medicines and chemicals. I am pleased to advise the Senate that the Senate Community Affairs Legislation Committee has inquired into the bill and recommended in its report of 7 August that it be passed without delay.

The committee identified two principal issues relating to feedback on consultations undertaken by the government and on the new scheduling arrangements and the constitutionality of the arrangements. As the Parliamentary Secretary for Health addressed these issues and the government’s response in his speech to the House, I will not repeat that detail here but instead provide a brief summary.

Since 2001, the Therapeutic Goods Administration, TGA, has undertaken a series of negotiations with both state and territory governments as key partners in scheduling as well as consultations with industry. I am pleased to confirm that, following the most recent consultations in May, feedback on submissions made during the consultation has been posted on the TGA website. The government is committed to open and cooperative consultations with industry, and further consultations are set to occur with industry to finalise the details of the arrangements we established under this bill.

In regard to the constitutionality of the new arrangements provided for in this bill, the government has received legal advice confirming that the ongoing involvement of the Commonwealth in partnership with the states and territories in the scheduling of substances is supported by the Constitution. The bill also makes a number of smaller changes to the act to improve its operation. The amendments in this bill are the third instalment in an ongoing program of reform to the act. The government is committed to ensuring that the regulatory arrangements for therapeutic goods in Australia continue to meet the need of Australians to access safe and effective therapeutic goods. The bill continues that commitment. I commend the bill to the Senate.

Question agreed to.

Bill read a second time.