Rachel Siewert (WA, Australian Greens) Share 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.