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Wednesday, 9 September 2009
Page: 6060


Senator XENOPHON (10:46 AM) —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.