CODEX Archives

New Zealand--Microcosm for the USA? Archive in CODEX.

Comments?
Misty L. Trepke
http://www.searching-alternatives.com

Vitamin Consumers World Wide Must Be Aware of Ongoing New
Zealand Struggle to Throw Off Yoke of Pharma Oppression

Date: 12 May 2004 17:51:09 -0000
From: "IAHF.COM"
Subject: Vitamin Consumers World Wide Must Be Aware of Ongoing New
Zealand Struggle to Throw Off Yoke of Pharma Oppression

IAHF Webmaster: Whats New, Asia, What to Do, All Countries, Codex

IAHF List: See REMINDERS below re health freedom radio shows Tonight
and Tomorrow, (shows will be archived) and please forward this
widely, encouraging more people to sign on to the IAHF list at
http://www.iahf.com We're closing in on 2,000 subscribers as
awareness of the awful slow motion train wreck that we're struggling
to stop ensues.

Regardless of where you live in the world, the New Zealand situation
discussed below is highly illustrative of what all of us are up
against as the New World Order attempts to crush the sovereign law
of ALL nations and to strip us of access to immune boosting
supplements.This is a planned GENOCIDE agenda, seen in microcosm in
New Zealand RIGHT NOW!!

Just as New Zealand is threatened with the destruction of its very
liberal food based vitamin laws by powerful neighbor Australia, so
is the whole PLANET threatened by what is happening in the EU and at
CODEX. See Josef Hasslbergers excellent article below which contains
an update from Sue Kedgely, member of the New Zealand Party who is
spearheading an ongoing New Zealand health freedom battle that is by
no means over.As Josef's article contains hypertext links that did
not copy into this message, I incourage you to view his article at
the link provided.

REMINDERS: Robin Falkov, L.Ac from the IAHF Speakers Bureau will be
on Coast to Coast AM With George Noory tonight (May 12) from 10PM- 1
AM Pacific Time; 11 AM- 2 AM Mountain Time, Midnight- 3 AM Central
Time, 1 AM-4 AM Eastern time; 6AM- 9AM UK Time, 7AM-10AM European
time.

This call in Program is web based http://www.coasttocoastam.com
The show will be archived.

Robin, a licensed acupuncturist will address the extreme GLOBAL
threat posed by the EU Food Supplement Directive and will also
discuss alternative medicine in a broad sense.

John Hammell will be on "Update on Health" with host Pieter Taams,
MD, ND on Thursday May 13th from 5PM-6PM Pacific Time, 6-7 Mountain,
7-8 Central, 8-9 Eastern, 1-2AM UK, 2-3 AM Europe Program is web
based http://www.talknetradio.com Program will be archived at
http://www.naturopathic-retreat.com/radio-show-archive.htm John will
provide an in depth discussion of the global importance of the ANH
lawsuit to overturn the EU Food Supplement Directive placing it in
the Context of the larger Codex vitamin issue.

http://www.newmediaexplorer.org/sepp/2004/05/10/new_zealand_supplemen
ts_to_be_medicines.htm

New Zealand: Supplements to be 'Medicines'

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 - including withdrawing product licenses, shutting
down companies, a la Pan fiasco, which has cost the Australian and
New Zealand industry more than $400 million to date.

An all-powerful Managing Director will take over the powers of
regulatory decision-making and enforcement presently exercised by
the Minister of Health. Parliament will be asked in implementing
legislation to delegate law-making power to the Managing Director
who will be able to make all regulatory decisions on his own, as the
treaty says he will not even be accountable to the Board for
regulatory functions - let alone to the New Zealand Parliament.
Curiously, the unelected and unaccountable Managing Director will be
able to delegate the power to make decisions to other persons and
organisations of his choice (it's bound to be a he).

The government has dressed up this abdication of sovereignty by
saying that the Minister of Health will have equal decision-making
powers with the Australian Minister of Health on a Governing
Council, and that New Zealand will have good representation on a
Board which will set budgets and strategy for the agency. The only
problem is that the key regulatory decision-making powers are all
delegated to the Managing Director!

In essence, then, the proposal is that we hand over control and
sovereignty of a vital New Zealand industry to an expensive, highly
bureaucratic Australian-based organisation over which our Parliament
will have no effective control. The only beneficiaries of this
astonishing abdication of our sovereignty will be Australian
businesses, which will have a competitive advantage in the New
Zealand market, and the government, which will save $3 million in
compliance costs by passing these costs to the dietary supplements
industry.

In return for this, compliance costs will escalate, small businesses
will go to the wall, the cost of dietary supplements will increase,
entire brands of dietary supplements will be taken off the market,
and consumers will have less choice.

It is worth remembering that the whole point of pursuing Trans
Tasman Mutual Recognition with Australia was to benefit New Zealand
business and consumers by eliminating regulatory impediments to
trade with Australia. But the effect of harmonising with Australia
through the joint agency will be to burden New Zealand businesses
with increased compliance costs and regulatory impediments (which
will be passed on to consumers), and open up competitive trading
opportunities for Australian businesses, which will likely wipe out
many New Zealand businesses.

Pursuing mutual recognition, instead of harmonisation through the
TTTGA, would ensure that New Zealand businesses could trade more
freely with Australia without incurring excessive compliance costs
and getting tied up in the over zealous bureaucracy of the
Australian TGA, or giving up our sovereignty.

If anyone still has any doubts about the effect the proposal would
have on industry, let me quote from an email I received from Bruce
Murrary, Managing Director of Nature's Sunshine Products New
Zealand. Bruce had just returned from attending a two-day conference
in Australia about TGA regulations. He concluded "I cannot emphasise
more the fact that harmonising with the TGA will ruin all innovation
and many of the fine, 30 year formulations manufactured by my
company will disappear as we struggle to meet the pre & post
production testing costs and reformulate our products as numerous
ingredients we use are not on the TGA white list."

To ensure that all political parties continue to oppose this
proposal, I would urge people to contact MPs in the coming months
which will be decisive. It is probably worth contacting the
government as well, which presumably is more sensitive to public
opinion at this time.

Let me assure you that the Green Party will not waver in our
opposition to the joint agency proposal - our party policy is
opposed to handing over our control and sovereignty of this
important industry to an Australian based organisation.

Australians seek tighter controls on dietary supplements

After the Pan fiasco, the Australian government set up a 16 member
expert committee to look at whether regulatory controls over
complementary medicines needed to be further strengthened. Only four
members of the committee had any formal training in complementary
medicine.

The committee has released its report that contains a wide range of
recommendations to further strengthen the regulation of
complementary medicines - recommendations that would have an
immediate impact in New Zealand if we were to be regulated by the
TTTGA.

The committee recommends that homeopathic medicines be regulated:
that herbal medicines and the use of raw herbs in medicines be
reviewed, to bring them into line with the regulation of other
complementary medicines. It proposes ensuring that legally
enforceable quality standards are in place for all complementary
medicines; removing Practitioner Only dispensing products,
increasing penalties to companies who refuse to provide information
to support claims they make on products etc. The Report
(Complementary Medicines in the Australian Health system) can be
accessed on the Australian TGA website.

Health Practitioners Competency Bill

The Health Practitioners Competency bill was passed in Parliament
last year and will come into effect on 18 September 2004.

It will extend coverage to Osteopaths but not to Acupuncturists,
because the government did not support a Green Party amendment to
include Acupuncturists in the bill.

Professions which are covered by the bill are busily finalising
their scopes of practice and establishing Registration Authorities
to comply with the new legislation. The Osteopaths have already set
up a Registration Authority and are working on the scope of practice
for their profession.

Any profession which is not covered by the bill, such as the
Acupuncturists, can apply at any time to be covered by the bill. The
Ministry of Health has already received an application from
Physiotherapists to come under the bill, but has not yet received
one from Acupuncturists. I gather this is because the different
groups within the acupuncture profession have not yet managed to
resolve their differences, which is a real shame, as most people
agree that Acupuncture should be covered by the bill.

Pan Pharmaceuticals recall

The recall of about 700 Pan Pharmaceutical dietary supplements has
cost the Australian and New Zealand dietary supplements industries
more than $400 million to date. 143 tonnes of the recalled dietary
supplements were destroyed without ever being tested, so there is no
analytical evidence that any of the dietary supplements actually
posed a risk to New Zealand consumers.

In my last newsletter I expressed concern that the massive mandatory
recall was pushing many small businesses to the brink of financial
collapse and had been used to tarnish the reputation of the dietary
supplements industry - even though the two products that had sparked
the recall were over-the-counter pharmaceutical products.

While the Green party strongly supports GMP appropriate standards
for pharmaceuticals and dietary supplements, and acknowledges there
were serious problems at Pan Pharmaceuticals, I am concerned that
the dietary supplements industry has been unfairly targeted by
regulatory authorities over the Pan Pharmaceutical recall.

Since then I have been asking numerous questions of the Minister of
Health about the Pan Pharmaceutical recall. Her answers raise as
many questions as they answer - such as why, if the largest ever
recall was prompted by fabrication and manipulation of tests etc, as
she claims, has nobody ever been prosecuted for the alleged crimes,
or any criminal charges laid, and why have none of the recalled
products ever been tested?

I print in full a sample of the Minister's answers to my questions.

3039 (2004). Sue Kedgley to the Minister of Health (18 March 2004):
Has anyone been arrested or prosecuted for alleged crimes relating
to Pan Pharmaceuticals; if so whom; if not, why not?

Hon Annette King (Minister of Health) replied: No one has been
arrested or prosecuted in New Zealand.

1291 (2004). Sue Kedgley to the Minister of Health (23 February
2004):Were any Pan Pharmaceutical products that were recalled also
destroyed; if so, why?

Hon Annette King (Minister of Health) replied: All Pan
Pharmaceuticals medicines and dietary supplements that were recalled
in New Zealand were destroyed. Because Pan Pharmaceuticals'
manufacturing licence had been suspended, there was no confidence
that these products had been manufactured to an appropriate
standard. The destruction of dietary supplements was in accordance
with section 40 of the Food Act 1981.

1292 (2004). Sue Kedgley to the Minister of Health (23 February
2004):If Pan Pharmaceutical products were destroyed, what volume was
destroyed and where?

Hon Annette King (Minister of Health) replied: A total of 20,359
units of Pan Pharmaceuticals medicines were destroyed in New
Zealand. In excess of 143 tonnes of dietary supplements were
destroyed at various centres in New Zealand, primarily in Auckland.

1295 (2004). Sue Kedgley to the Minister of Health (23 February
2004):Were any of the Pan Pharmaceutical products that were
destroyed the subject of reported adverse reactions or death; if so,
what are the details?

Hon Annette King (Minister of Health) replied: Further to the
interim reply to this question, I am now able to provide the
information requested.

No direct linkage was established in New Zealand between Pan
Pharmaceuticals products and adverse reactions or death.

1294 (2004). Sue Kedgley to the Minister of Health (23 February
2004):What were the test results of any of the Pan Pharmaceutical
products that were recalled and tested?

Hon Annette King (Minister of Health) replied: No products were
tested in New Zealand.

3130 (2004). Sue Kedgley to the Minister for Food Safety (19 March
2004):Further to her reply to written question No 01293 (2004), what
are the appropriate standards in Section 40 of the New Zealand Food
Act that were breached an that therefore initiated the recall of Pan
Pharmaceutical products in New Zealand?

Hon Annette King (Minister for Food Safety) replied: The standard
applied that resulted in a recall of Pan Pharmaceutical products
being initiated was that set out in section 40(1) of the Food Act
1981 relating to protecting the public. Section 40(1) states that
this protection can relate to "any food that is unsound or unfit for
human consumption or is damaged or deteriorated or perished, or that
is contaminated with any poisonous, deleterious, or injurious
substance."

In terms of the decision to recall, protecting the public was
paramount and this was made initially on the basis of the reported
extent of non-compliances of Pan Pharmaceutical manufacturing
practices (including data manipulation, results fabrication,
ingredient substitution, deficient raw material and finished product
controls, unsatisfactory process controls and inadequate assurance
regarding mix-up +/- (cross) contamination) that resulted in the
suspension of the Pan Pharmaceutical licence by the Australian
Therapeutic Goods Administration and the impact such non-compliances
would have on products from Pan Pharmaceuticals.

posted at May 10, 2004 12:23 PM
For Health Freedom,
John C. Hammell, President
International Advocates for Health Freedom
556 Boundary Bay Road
Point Roberts, WA 98281-8702 USA
http://www.iahf.com
jham@iahf.com
800-333-2553 N.America
360-945-0352 World