New Zealand: Supplements to be 'Medicines'

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Legislation

For Europeans and Americans, New Zealand and Australia seem so far away we don't usually think that what happens "down under" is going to affect us in any way. Better think twice. What is happening there does have relevance to us. In fact we are facing attempts by the European Union and by the FDA to "regulate" supplements that are not dissimilar to what is happening on the other side of the world.

Clearly, people taking care of their own health with non-medicinal nutritious products are anathema to the medical/pharmaceutical juggernaut that is controlling government health authorities and is running roughshod over our health and well being. Their global war against natural medicine is in full swing, just like the global war against "terror", which is leading us right into a future UN-controlled dictatorship. We even have our own 911 equivalent - the recall and immediate destruction of more than a thousand innocent natural products, operated last April by the Australian Therapeutic Goods Administration.

The plan is to now form a joint Australian/New Zealand Agency for the control of Medicines (TGA), which is expected to end many of the freedoms New Zealanders have traditionally enjoyed when it comes to taking care of their own health using natural health products. The agency is to be modeled after the existing Australian TGA, sadly famous for its unprecedented natural products recall, which Australian industry charges was a hatchet job. Not one of the products recalled and destroyed immediately has been shown to be harmful in any way.

New Zealand member of Parliament Sue Kedgley of the Aotearoa Green Party is actively opposing the planned Australian takeover of her country's health system. Her May 2004 newsletter charges that the takeover could lead to the demise of much of New Zealand's natural products industry, not to speak of diminished freedom for New Zealand consumers of natural health products, which in the future are to be classified as medicines.

From: Sue Kedgley
Sent: Wednesday, May 05, 2004
Subject: Complementary Health Newsletter - No. 1 for 2004

Welcome to the first 2004 edition of my Complementary Health Newsletter.

There is a lot to report on since my last newsletter. The saga of the government's attempt to hand over control of our dietary supplements industry to an Australian-based regulator goes on, and has reached a critical phase, so I will bring you up to date on the latest developments on this and other issues. It is vital that ordinary New Zealanders who care about these issues let the government know what they think of its handling of these issues, so please feel free to forward this newsletter to anyone who might be interested.

In this edition:
- Update: Govt. tries to give Australian agency control of NZ supplement industry
- Australians Seek Tighter Controls on Dietary Supplements
- Health Practitioners Competency Bill
- Pan Pharmaceutical Recall

Update: Govt. tries to give Australian agency control of NZ supplement industry

As you will know the Health Select Committee inquiry into dietary supplements (which was triggered by the Green Party's 30,000 strong petition to the Committee) recommended that New Zealand should not regulate our dietary supplements industry through an expanded Australian based Therapeutic Goods Administration (TTTGA).

Instead, the Committee recommended unanimously that we strengthen New Zealand's own regulatory system and pursue Mutual Recognition rather than a joint agency with Australia.

A few days before our report was to be released, the government signed a treaty with Australia committing New Zealand to regulating dietary supplements through an expanded Australian TGA - ignoring the recommendations of the yearlong inquiry and the overwhelming majority of submitters to the Inquiry.

This was particularly galling given that all four of Labour's MPs on the Health Sect committee had supported the committee's recommendation.

MPs from National, Greens, New Zealand First, Act and United Future all held a joint press conference condemning the government's actions.

Fortunately, however, implementing legislation has to be adopted by Parliament before the treaty that the government has signed can come into force. Hopefully the government will find that it does not have the numbers in Parliament to pass the implementing legislation - which would be highly embarrassing for the government.

At this stage all parties other than Labour and the Progressives have indicated they will not support implementing legislation to regulate of dietary supplements through the TTTGA.

Despite this, the government is charging ahead as if it had the numbers to pass legislation implementing the treaty it has signed. The treaty has been sent to the Health Select committee for consideration‚ and legislation implementing the treaty is expected to be introduced into Parliament in the next few months.

Parliament does not have the power to amend treaties between governments, but the Health Select Committee can recommend to government that it not ratify the treaty, as it relates to dietary supplements and hopefully that is what the committee will do.

During hearings in the Health Select committee on the treaty and the proposed new joint agency, all of the concerns and fears that the industry and consumers have raised over the past few years have been confirmed.

As part of the treaty examination process, the government has had to conduct a National Interest Analysis of the proposal, and has finally made public its Regulatory Impact Statement of the likely impact joining the TTTGA will have on New Zealand businesses and consumers.

These documents confirm that regulating our dietary supplements industry through the TTTGA will lead to significant increases in compliance costs for manufacturers and distributors of complementary medicines, especially smaller, New Zealand based companies: higher prices for consumers and some brands being taken off the market, leading to decreased consumer choice.

They confirm that all dietary supplements will be classified and regulated under the same system as medicines. This means that dietary supplements will be regulated out of all proportion to their profile of risk, using an inappropriate pharmaceutical methodology, by a pharmacy dominated regulator - even though there are significant differences in risk levels, ingredients and philosophies between the two industries which are in effective competition with each other.

They acknowledge that in terms of how the new agency will operate it will simply be an expanded version of the present TGA - effectively a case of the TGA extending its authority and control to New Zealand - despite the fact that we were constantly assured during the Health Select committee inquiry that the new agency would be quite different from the existing TGA.

They confirm that the new agency will be 100% cost recovery which means that all the costs of operating the highly bureaucratic trans tasman agency will be paid for by industry itself. It estimates that New Zealand businesses will be required to pay $3.2 million a year in fees to the TTTGA. This is on top of the costs manufacturers will incur in obtaining product licenses for every single product they sell, and for meeting Good Manufacturing Practice standards which are essentially the same as those for pharmaceuticals. It says all companies (whatever their size) will have to upgrade their facilities to GMP standards or cease manufacturing.

They say the greatest impact of the increased compliance costs will fall on small businesses, and on companies that import large numbers of products from different manufacturers. It says that unless the importers can ensure that all companies they import products from have Australian style GMP licensing, these companies may need to find alternative sources of product!

They acknowledge that there has been no direct consultation with industry on the costs of regulation. Then say one of the benefits of the new scheme is that government will be able to transfer $3.1 million in costs to the dietary supplements industry.

An Australian government's Regulatory Impact Statement acknowledges that „Australian businesses which already have approval in Australia (that is, all of them) will have an "early competitive advantage" over New Zealand firms having to seek local approval for new products, and will benefit financially from having products on the market earlier than (New Zealand) firms, with the potential for enhanced profit.

They acknowledge the likelihood that companies - both pharmaceutical and dietary supplements manufacturers - will shift their operations to Australia, as a result of high compliance costs, reducing the New Zealand government's tax take.

They confirm that the new agency will be headquartered in Australia and will have legal personality‚ in Australian domestic law. It will be the first in the world where an agency in one country has total control to regulate and enforce an industry in another country. The agency will not only make all decisions and regulations about dietary supplements, it will also monitor these regulations and have powers to enforce and police the entire dietary supplements industry in New Zealand - includ