NZHT Press Release
Auditor General’s report undermines public confidence in Health policy

A damning report from the Auditor General into contracts let by Ministry of Health to former employees has cast serious doubt on policy work around the Joint Trans Tasman Agency (JTA) to regulate natural health products. click here for the PDF

Auditor General report into MoH contracting procedures..

We were particularly concerned about a series of contracts entered into by the Ministry for the Joint Therapeutic Agency project (the JTA project). The first of these contracts was awarded to Allen & Clarke in January 2002. The contract was awarded on a non-contestable basis, and payments were made on an hourly rates basis. The value of the contract was $109,511. Three further contracts with Allen & Clarke in 2003 and 2004 had a combined value of more than $430,000, giving a total for the project of more than $539,000.

We had 2 concerns. First, there was no contestability for these contracts, either at the start of the JTA project or when it was extended, despite advice from the Ministry's internal auditor on 19 December 2003 that "once the current phase of the work is completed, and at a point convenient to the Ministry - we should not continue with Allen & Clarke without testing the market through a tender process". Second, there appeared to be a lack of succession planning and risk management by the Ministry, both with the initial contract, and at the extension of this project during the next 2 years.
click here for full report

NZ Health Trust - TGA delay another nail in the coffin of Government’s doomed TGA proposal

“It’s not delayed, it’s dying,” is how the natural health product sector interprets the latest announcement from State Services Minister Annette King.

Today Government announced that legislation enabling the unpopular Trans Tasman Therapeutic Goods Agency (TGA) has been delayed again due to opposition from the industry and MP’s. download PDF for full story

Drop diet supps from trans-Tasman agency, say Greens

The Government won’t have the numbers to get the Trans-Tasman Therapeutics Goods Agency through Parliament as long as dietary supplements are part of its brief, Green Party Health Spokesperson Sue Kedgley says

Trans Tasman Agency Not A Done Deal    
Press Release by New Zealand First  at  2:47 PM, 12 Dec 2005

An announcement that the Australia New Zealand Therapeutic Products Authority will be going ahead albeit with a delayed start-up date is well and truly putting the cart ahead of the horse, says New Zealand First's health spokesperson, Barbara Stewart MP.

"The appointment of a transitional director also indicates that both governments consider the establishment of the agency to be a done deal.

"There has in fact been a significant level of resistance to the whole concept of a trans-Tasman agency and considerable opposition to regulation of such items as dietary supplements. It is difficult to see where the Government can obtain the support for the enabling legislation," said Mrs Stewart.

"The original treaty was signed in spite of community opposition and against the recommendations of the Health Select Committee.

"Any further action on either side of the Tasman to establish the authority should immediately be put on hold until such time as the necessary legislation is presented to Parliament and a final - democratic - decision is made," said Mrs Stewart.

ENDS

Hon Tony Ryall

National Party Health Spokesman

11 December 2005

Trans Tasman Therapeutic Goods decision “inevitable”
National’s Health spokesman, Tony Ryall, says Labour’s decision to delay the joint Trans Tasman Therapeutic Goods Agency was “inevitable”.

“The fact is, Labour does not have the numbers in Parliament to force New Zealand into what could become an overly-bureaucratic regulator.

“New Zealand industry and consumers must be assured that compliance costs associated with this joint agency will be minimised.

“Labour should be working with other parties in Parliament to ensure New Zealand’s interests are protected.

 “Until that happens, Labour will not be able to pass any laws in this area,” says Mr Ryall.

TGA agrees to infringement appeals

Posted 28 November 2005

The TGA has agreed to adopt an informal appeal regime for infringement notices issued under the new sanctions bill following negotiations with complementary medicines industry representatives.

When the bill becomes law, the regulator will be able to issue infringement notices to companies that it suspects - on the basis of independent legal advice - are in breach of the Therapeutic Goods Act.

Originally the TGA''s view was that anyone who received such a notice could either choose to pay the fine it imposed or take the matter to court.

Now it has agreed to an intervening step under which infringement notices can be contested by the recipient providing additional facts it believes should be taken into account, Doug Kentwell, principal of regulatory consultants, Regulatory Solutions, told an Association of Clinical and Regulatory Scientists meeting in Sydney last week.

It would be open to the TGA to withdraw the notice on consideration of the additional material, Mr Kentwell said.

However, he said companies issued infringement notices could still choose to defend them in the Federal Court although this option could be risky and was expensive with a two day court hearing costing up to $100,000.

Mr Kentwell said that industry concern over a widening of section 61 of the Therapeutic Goods Act that would permit the TGA to issue press releases publicising infringement notices if it chose to do so remained unresolved.

"The TGA in recent years has had the propensity to issue media releases and media releases of themselves can be extremely commercially damaging to a company," he said. But despite attempts to convince the regulator to incude in regulations principles on release of information to the media set out by the Australian Law Reform Commission in 2002, it had so far declined to do so.

These principles include that any release should stress that an infringement notice contains only allegations of misconduct and that any finding that no misconduct has taken place is given equal publicity to the original allegation.

Mr Kentwell said an attempt would be made to have a provision to this effect included in guidelines being developed by a working group established by TGA national manager, David Graham. He said a recently distributed set of draft guidelines stated that media releases would only be used if there was a public health safety risk.

"The regulator has put that qualification on it but still circumstances may arise where they put out a media release alleging an offence subsequently proven to be incorrect and the industry feels that that should be corrected," he said.

Canadian "Health Freedom" Wins a BIG ONE...
Opinion by Consumer Advocate Tim Bolen

Friday, November 25th, 2005

The Canadian "Health Freedom" movement spells the word "AGGRESSIVE" in all capital letters. A few years ago concerned citizens from all across Canada gathered together and decided, like Californians, that they wanted "the best health care they could get - and they wanted it RIGHT NOW..." read full story

Health Freedom Protection Act (HR 4282) Introduced Into US Congress...
Opinion by Consumer Advocate Tim Bolen 

Sunday, November 13th, 2005  

The US Food & Drug Administration (FDA) was originally designed to serve the needs of the American public. 
Of course, these days, it does no such thing - it is owned, outright, by "Big Pharma," the very industry it is supposed to regulate... read full story

Canadian "Health Freedom" Wins a BIG ONE...
Opinion by Consumer Advocate Tim Bolen

Friday, November 25th, 2005

The Canadian "Health Freedom" movement spells the word "AGGRESSIVE" in all capital letters. A few years ago concerned citizens from all across Canada gathered together and decided, like Californians, that they wanted "the best health care they could get - and they wanted it RIGHT NOW..." read full story

Health Freedom Protection Act (HR 4282) Introduced Into US Congress...
Opinion by Consumer Advocate Tim Bolen 

Sunday, November 13th, 2005  

The US Food & Drug Administration (FDA) was originally designed to serve the needs of the American public. 
Of course, these days, it does no such thing - it is owned, outright, by "Big Pharma," the very industry it is supposed to regulate... read full story

Letter to the Editor

Your article of 27 September (A3, “NZ woman joins suit against Vioxx”) highlights the failure of medicine regulators in NZ.

When a patient is told a drug will kill her, give her a stroke or dissolve a clot, it’s time to ask how Vioxx ever got approved.  Especially when these same regulators are currently working overtime to ensure many natural health products are regulated out of existence.

Who, at the end of the day, is held to account for Vioxx?  Merck continue largely as before and the regulators who declared it safe for public sale face no consequences at all.  But under proposed new laws many dietary supplements will disappear from our shelves as supposedly ‘unsafe’.

How about you forget the vitamins and protect us from dangerous drugs. There is clearly a regulatory double standard and the consumers are the poorer for it.

Yours faithfully

Amy Adams
NEW ZEALAND HEALTH TRUST

A good explanation how Codex and their 27 committees work -
Codex Delegate Sounds The Alarm: Health Freedoms Face Serious Threats Worldwide
Click here for to read

Not surprisingly, traffic accidents were common. Cars would crash into each other at nearly every intersection. But business was booming for the auto repair shops and local hospitals, which dominated the economy of Allopath.

Jury: Merck negligent
Merck blamed for death in Vioxx suit; jury awards $253 million in damages.

NEW YORK (CNN/Money) - Merck has been held liable by a Texas jury in the first lawsuit involving its former blockbuster drug Vioxx, in a case that could have a profound effect on thousands of other cases filed against the company. read more...

EU Food Supplement Ban Avoided

Date: 8/05/05 Author: Press Release, Source: Alliance For Natural Health

ANH PRESS RELEASE: European food supplement ban avoided
1 August 2005 - for immediate release

Legal challenge and cooperation between industry and government avert wide-scale food supplement ban previously anticipated today.

FOOD SUPPLEMENT BAN AVOIDED BY MUTUAL COOPERATION

Today could have seen up to 5,000 vitamin and mineral products being banned from health store shelves in the UK alone, with further products being banned in other EU countries such as Ireland and Sweden .
Click here to read full article

ANH PRESS RELEASE: ANH Landmark Legal Challenge - The Verdict!

The European Courts of Justice today handed down its judgment and the ruling is far from doom and gloom! See ANH's preliminary interpretation below...

The European Court of Justice in Luxembourg today announced that it is upholding most aspects of the controversial EU Food Supplements Directive, after a landmark legal challenge by the Alliance for Natural Health. 
Click here to read this article

JUDGMENT OF THE COURT (Grand Chamber)

12 July 2005

(Approximation of laws - Food supplements - Directive 2002/46/EC - Prohibition on trade in products not complying with the directive - Validity - Legal basis - Article 95 EC - Articles 28 EC and 30 EC - Regulation (EC) No 3285/94 - Principles of subsidiarity, proportionality and equal treatment - Right to property - Freedom to pursue an economic activity - Obligation to state reasons)
Click here to read the full Judgment

NEWSFLASH! READ THE LATEST ON CODEX FROM ROME

SUPPLEMENT ACTIVISTS ASSESS CODEX STRATEGIES GOING FORWARD
by James S. Turner, Esq., Board Chair, Citizens for Health

Rome, July 5, 2005: After the second day of CODEX Commission Rome meetings, in a room provided by the US CODEX delegation, fifteen North American and European advocates for the consumer right to dietary supplement choice met and explored several possible avenues of action to blunt the impact of the Commission's approval of restrictive vitamin and mineral trade guidelines. While the guidelines are the first step toward worldwide restriction of dietary supplement access, they have only indirect impact on national supplement regulation until adopted by national governments.
to read more updates starting from 3rd July 2005 click here

Vioxx and Pan recalls - TGA inherent pro pharmaceutical bias

The Pan recall of complementary products covered over 1 billion doses and yet only 62 adverse reactions were noted. Of those only 2 could be shown to have been actually manufactured by Pan and those 2 reactions involved hypertension and an allergic reaction. Amazingly though the Pan recall was carried out as a Class 1 recall - the most serious possible, supposed to be used for potentially life threatening situations.

Compare this to the recall of Vioxx, a prescription medicine linked to significant numbers of heart attacks, which was recalled only as a class 2 recall - the recall for defects that could cause illness or mistreatment. It's hard to see what else you need to see the inherent pro pharmaceutical bias of the TGA.

Click here to see the reports of the debate in the Australian senate where TGA officials are taken to task over this very point."

documentary "WE BECOME SILENT"

Please show this documentary to everyone you know who maybe interested

Recommended for ADSL or cable only or on the sites listed below
Click here for movie preview in Quicktime :
'WE BECOME SILENT' Video (28 Min.) (76.5 Megs)

Windows Media Player link
http://herballure.com/Special/WeBecomeSilent/WindowsMedia.html

Flash Streaming media Link below - more suitable for low Bandwidth
http://www.nzhealthtrust.co.nz/vid/we_become_silent.html

Other Quicktime Links below
http://www.alliance-natural-health.org (high bandwidth)
http://www.herballure.com (high bandwidth)
http://www.iahf.com/wbs-weba.mp4 (medium bandwidth - download and play only) http://www.coalitionforhealthfreedom.org/documentaries.html (high bandwidth)
http://www.healthfreedominternational.org (low bandwidth)
http://www.glycommunity.com (still to be posted)
http://www.welltv.com (medium bandwidth)
http://www.evehillary.org/we.become.silent.htm (medium bandwidth)

International award-winning filmmaker Kevin P. Miller of Well TV announced the release of a new documentary about the threat to medical freedom of choice. 'We Become Silent: The Last Days of Health Freedom' details the ongoing attempts by multinational pharmaceutical interests and giant food companies - in concert with the WTO, the WHO and others - to limit the public's access to herbs, vitamins and other therapies.

'We Become Silent' is narrated by Dame Judi Dench, the noted UK actress who has won multiple Golden Globe awards, an Oscar, and a Tony for her on-stage work, in addition to dozens of other honors throughout her prestigious career.

During the 1990s, the legendary James Earl Jones narrated Miller's film, 'Let Truth Be The Bias.' This hard-hitting film exposed the government's role in a guns-drawn raid at the office of a noted holistic MD, and highlighted the U.S. government's complicity in suppressing the truth about the effectiveness of alternative/complementary medicines. 'Truth' successfully mobilized public support around the Dietary Supplement Health Education Act (DSHEA), which defended U.S. consumers' rights to health alternatives.

"I am releasing a 30 minute version of 'We Become Silent' because it is vital to engage the worldwide public about the dangers of CODEX ALIMENTARIUS," said Miller. "If we don't defend our health freedoms, they will be lost - and nothing would make the drug companies happier than to have free rein over our health."

'We Become Silent' features the only known video from inside a Codex meeting, exclusive interviews with delegates to the Codex Alimentarius Commission, U.S. Food and Drug Administration officials, two U.S. Congressmen, actor Mel Gibson, and more. Consumer activists like Dr. Robert Verkerk of Alliance for Natural Health play a major role in the documentary, as do Julian Whitaker, MD, Dr. Carolyn Dean of Friends of Freedom International, Scott Tips of the National Health Federation, John Hammell of International Advocates for Health Freedom, and many of the best-known health freedom advocates from around the world. 'We Become Silent' is a powerful statement about the dominance of multinational corporations over personal freedoms, the WTO, Codex, and the challenges consumers face in trying to repel this monolith from their daily lives.

'We Become Silent' will air in the USA on WorldLink Television (25 million US homes) and Well TV is aggressively courting UK, Canadian and European TV networks as well. It will be available for sale and distribution to health food stores, doctors, and consumers worldwide through the Internet.
.

National Health Federation Urgent Alert - CAFTA  
WE MUST NOT ALLOW CAFTA AND CODEX TO OVERRIDE DSHEA

The Central American Free Trade Agreement (CAFTA) Treaty will require the U.S., a member of the World Trade Organization, to revise our food laws and regulations based on Codex decisions. CAFTA would force harmonization of our dietary supplements and regulations to international standards, overriding the DSHEA Act of 1994.

NZHT Media release: 30 June 2005

Government should give up on Natural Health Product proposal too

Since the Government undertook a policy u-turn on land access yesterday, there has been a call from the natural health product sector for Government to give up on plans to hand industry regulation over to Australia.

Public opposition to the proposed Trans Tasman Joint Regulator for natural health products is equally strong, according to a consumer watchdog group the New Zealand Health Trust.

Latest independent research showed that 61% of New Zealanders oppose Health Minister Annette King's plans to hand control of the industry to the Australian-dominated agency.

"That's more than 2 million people who don't want the Joint Agency to go ahead," said Amy Adams, spokesperson for the NZ Health Trust.

"There is massive political opposition, so Labour doesn't have the numbers to pass the legislation. So we say 'just give up now' and stop wasting taxpayer's money employing staff for the new agency and holding pointless meetings all around the country," Mrs Adams said.

"What's one more back down on an unpopular policy in the lead up to the election?"

ENDS

For further information please contact
Amy Adams (021) 499-066

Australian Therapeutic Goods Amendment Bill 2005

We have commented before on the extensive new penalties regime proposed by the Australian TGA however we thought it was timely to look at this issue once again.

The Amendment Bill is currently set to be introduced to the Australian Parliament and if passed would bring into force a regime of penalties and enforcement actions which would give the TGA unheralded and almost unbridled power. read more... click here for the PDF

How The Bill Would Increase Penalties for Natural Medicines (Natural Health Products)
Click here to view A table of existing and propsed penalties relating to Natural Medicines by Mike Browning - this has not been checked by NZHT, however if you read the PDF below you will see the penalty units associated to each offence. 1 penalty unit = AU$110

Australian Government Therapeutic Goods Amendment Bill 2005 Click here for the PDF file

Fluoridation

A report prepared for the ministry of health, by Ann Winstanley, Sept 2002, on how to best manipulate the people and councils of New Zealand to put Fluoride in drinking water. Click here to read PDF 340k (72pages)

The Christchurch Press - Article
District Health Boards working for Minister not the public Click here to read PDF 83k

The Christchurch Press - Article
Good news one CCC councilor says " he would not touch Fluoridation with a barge pole, its about time we put the whole subject to rest" Click here to read PDF 99k

Go to this link: http://www.idof.net/
FLUORIDE 'CAUSES CANCER'
Irish Dentists Opposing Fluoridation (IDOF), a group of over 100 dentists, is demanding an immediate stop to the dosing of all public water supplies with chemical fluoride after a study conducted by the Harvard School of Dental Health found an increased cancer risk in children.

Risk model on supplement levels prompts concern for EU law
click here to read this article

20/01/2005- The first attempt in Europe to set maximum safe levels for nutrients in supplements and fortified foods demonstrates that numerous products could be considered unsafe if the same approach is adopted across the European community.

Regulator plan at risk

The planned Australia-New Zealand joint therapeutic goods regulator meant to create a single therapeutics market could be scuttled by opposition to the plans in the NZ parliament and the NZ elections expected later this year.

Critics say the NZ minority government is stalling because it doesn't have the necessary support to get the laws through.
And if Labour is defeated at the NZ election, the plans could be shelved indefinitely.

The joint regulator was meant to be operating by next month, but earlier this year the start date was delayed until July 2006. Both governments cited the need for further consultation.

Last month an interim advisory committee was set up to "oversee the establishment of standards" under the new agency.

"It's spin," NZ Health Trust spokeswoman Amy Adams said. "They're hoping that if they tell us enough times that [the agency] is a done deal that the opposition [parties] will vote for it."

An Australian Department of Health and Ageing spokeswoman said Australia "is on track" for July next year "and there is no indication that NZ is not, but you would have to talk to NZ about NZ issues".

Annabel Stafford

The Australian Financial Review

Parliament House Canberra 2600

The NZHT has been busy continuing its work to educate others about this issue and the threat New Zealand faces.  Set out below are brief  blurbs from recent articles and press release along with a link to get through to the full text.

WHATS GOING ON IN OUR HEALTH SYSTEM?
Investigate Magazine May 05
A report by the New Zealand Health Trust       

You've heard that question asked so many times but this is one story that has nothing to do with DHB's, PHO's or waiting lists.  It asks instead why it is that products like Vioxx and Celebrex make it on to our shelves only to be later recalled because of serious safety concerns .  And why the same regulators that happily allowed those products have shown no mercy toward the natural health industry despite its largely blameless record..
click here to read more

Money won't buy support for the TGA

NZHT Media Release

24 April 2005

Natural health sector gearing up for election battle

The Labour Government is being warned not to underestimate opposition to the
proposed joint agency to regulate natural health products, with latest independent
research showing that 62% of New Zealanders use some form of natural health
product or dietary supplement.

"That's 2.5 million New Zealanders, who are watching what this Government is
planning in the run-up to the election," said Amy Adams, spokesperson for consumer
watchdog the NZ Health Trust.

"Annette King should not underestimate these consumers - they care about their access
to these products and want the Government to recognise this is a main stream issue."

"They aren't going to be pleased if they see products disappearing from shelves,
Kiwi companies closing down or moving to Australia and the right of the New Zealand
Parliament to control the sector overruled by Australia ."

The natural health product sector is gearing up for a campaign against the Government's
proposal to allow an Australian-dominated agency to control a huge range of products
including vitamins, natural health products, herbal remedies and mineral supplements.

The proposed new agency has met with near unanimous political disapproval -
it is opposed by National, ACT, the Green Party, United Future and New Zealand First,
which means the Government currently has not got the numbers to pass the legislation
it has promised Australia it will enact by the end of this year.

ENDS

For further information contact
Amy Adams
(021) 499-066

NEWSMONITOR SERVICES LIMITED T R A N S C R I P T

Tel: 09 303 3826 Fax: 09 303 3827

Email: newsmon@newsmonitor.co.nz

DATE: Sun 24 Apr 05 06:03 PM PROGRAMME: News 1YA

ITEM Id: NWYA3484517 PRESENTER: Lloyd Scott

STATION: 1YA RECORD: A natural health

Document Id: 94584.2019 (C) Radio New Zealand Limited 2005

LLOYD SCOTT:
A natural health lobby group says the Government can't afford to ignore the high numbers
of New Zealanders being, using natural health products amid plans for a trans-Tasman
agency to regulate therapeutic products. The Government has deferred the launch of the
Agency until next July amid claims by opposition parties that it is expensive and unnecessary.
The New Zealand Health Trust is stepping up its campaign against the agency and says
recent research shows 62% of New Zealanders use products such as herbal remedies
and dietary supplements. A spokesperson, Amy Adams says the joint agency will reduce
product choice and increase compliance costs.

AMY ADAMS: We just want the Government to understand that the numbers of people usi
ng natural health products indicates that this is very much a mainstream issue for New Zealand.
And that it's not the fringe industry that they appear to have originally viewed it as.

SCOTT: Amy Adams from the lobby group of the New Zealand Health Trust.

Ends

USA - " Court Says FDA Ephedra Ban Too Broad" - to read about this go to
http://news.yahoo.com/news?tmpl=story&u=/nm/20050415/ts_nm/health_ephedra_dc_2

WASHINGTON (Reuters) - The Food and Drug Administration failed to prove certain "low dose"
ephedra supplements are unsafe, a U.S. court said in a ruling announced on Thursday that could
allow some types of the controversial weight loss pill back on the market. read more...

ABC Four Corners TV
NEWSREADER: Hundreds of thousands of Australians are being warned to stop taking a
popular arthritis medication because it increases their risk of heart attack.
The drug, Vioxx, has been withdrawn from sale around the world

Read the transcript by clicking here

Opinion by Consumer Advocate Tim Bolen

Thursday, April 7th, 2005

Just two days ago, in my newsletter article
The Coming "US Health Movement v. Big Pharma" Codex War... ,
I announced the demise of Big Pharma's attempt to shut down the supplement industry. 
But little did I know at the time that that day, Tuesday, April 5th, 2005, would go down in the
annals as a double-whammy of Big Pharma's murderous intent.  Wait 'til you read this.

Sit up straight.  For, this story you are almost NOT going to believe. I'm going to have to convince you with data. 
To do that I'm going to tell you that you are going to have to do what I just did - you're going to have to read a
126 page report just issued by the British government titled
"House of Commons Health Committee -
THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY"

Food Supplements Directive deemed invalid

Germany taken to court for calling garlic supplements medicines
Germany is being taken to court by the European Commission for treating garlic supplements as medicines.

In a Commission statement, vice-president Günter Verheugen, responsible for Enterprise, Industry and the Free Movement of Goods, said the case was a ‘clear cut’ example of national overregulation creating unnecessary burdens for business and hampering economic growth in the EU. Garlic preparations, such as capsules containing pure dried garlic powder, are marketed as foodstuffs in another member state. German classification of the supplements as medicines therefore constitutes a disproportionate and unnecessary obstacle to the free movement of goods under EU law, said the Commission. The case also points to recent legislation that was expected to clear up some of the confusion over the borderline between food supplements and medicinal products.

This Information was recently sent to us from an Australian supporter

Certification requirements under FTA: beyond the original intent?
Sponsors of listed therapeutic goods have been encountering problems complying with new regulatory requirements which came into effect at the beginning of the year. It appears that the new requirements will also affect sponsors of registrable OTCs writes Dr Deon Schoombie, scientific director, ASMI.

Several sponsors who submitted listing applications after 1 January, and were in possession of listing certificates, discovered later that their products had not been entered on the Australian Register of Therapeutic Goods (ARTG). Entry onto the ARTG did not occur because they had not provided certification under the new section 26 of the Act. As a result, marketing of those products would effectively amount to illegal supply. Exporters of listed therapeutic goods also ran into obstacles. One Australian contract manufacturer who submitted listing applications for the sole purpose of exporting will not be able supply overseas clients until the new certification requirements have been met.

These problems gave rise to a debate about the original intent of the Australia-United States Free Trade Agreement (FTA) and subsequent legislative amendments to the Therapeutic Goods Act 1989. ASMI and CHC independently sought legal advice and have raised the issue with the Parliamentary Secretary, the Hon. Christopher Pyne MP.

Section 26(1)(a)(a) was introduced into the Therapeutic Goods Act 1989 in response to Article 17.10.4 of the FTA. This article obliges Australia to provide certain measures in its marketing approval process designed to prevent the infringement of valid patents by new entrants (sponsors) prior to the expiry of the patent. The obligation arises only where the would-be entrant relies on evidence or information supplied by another person concerning the safety or efficacy of a product that was previously approved.

Products may be Listed or Registered on the ARTG in reliance on information declared by the Therapeutic Goods Administration (TGA) to be sufficient to satisfy it of the safety and/or efficacy of the new entrant's product and consequently there is no reliance on safety or efficacy information supplied by another person. It follows that Australia is not obliged under the FTA to apply those measures in such circumstances.

In these cases, sponsors neither lodge safety and/or efficacy data, nor do they rely on safety or efficacy data lodged with the TGA by another party to obtain entry on the ARTG. Sponsors rely for safety on the requirement that all ingredients in the product must be drawn from the TGA's designated list of substances that may be used as active ingredients in Listed medicines. Sponsors do not rely on previously lodged efficacy data, but rather have to find and hold their own support for their claims in the scientific literature.

For registrable medicines, containing a well-established OTC ingredient, safety and efficacy data are not necessarily submitted with the application if the sponsor is relying on public domain reference text information deemed acceptable by the TGA under the provisions stated in the Australian Regulatory Guidelines for OTC Medicines (ARGOM) for Well Established Ingredients. Both these regulatory mechanisms differ from the registration procedure (more often associated with prescription medicines) in which the TGA is expressly required to examine the quality, safety and efficacy of goods. In these instances a sponsor is required to submit information regarding the quality, efficacy and safety of the product or the sponsor may rely on the data of an already registered equivalent product to gain marketing approval.

ASMI is of the view that the blanket approach to listable and registrable goods under section 26 of the Therapeutic Goods Act made by Schedule 7 to the Aus-US Free Trade Agreement Implementation Act 2004, goes beyond what is necessary to implement the FTA. This new section introduced an increased level of regulation which does not translate into any benefit while causing a significant impost to sponsors. ASMI has no issue with the FTA and would also not wish in any way to hinder progress on agreeing conditions for data protection, including for unpatented complementary products.

We would like to ensure that amendments to the Act are consistent with the spirit and intent of the FTA and that there is a balance between the level of regulation, public benefit and the cost to sponsors.

We need your help right now!

We have recently become aware that despite its assurances to date, the National Party may be planning to support the Government's disastrous Trans Tasman Therapeutic Goods Agency (TTTGA) legislation. If the Government gets National's support, the legislation needed to create the new agency would be able to be passed.

If NZ adopts the TTTGA, economic experts say this will cost the country jobs as some businesses go under while prices go up and consumers have less choice.

Here is a list of actions we urge you to take NOW.

Here is a list of actions we urge you to take NOW.

1. Please go to the website page "Contact your MP"
   http://nzhealthtrust.co.nz/cgi-bin/massmailerMPs.cgi?
   to send an email to Opposition leader Don Brash and his health spokesman Dr Paul Hutchison, asking them not to turn their backs on the New Zealand natural health products sector.

2. Complete our "Urgent Support" request page if you haven't yet done so
   http://www.nzhealthtrust.co.nz/poll.php

3. Write, Ph & or Fax Don Brash
   ph:(04) 471 9509  Fax:(04) 473 3689

4. Write, Ph & or Fax Paul Hutchison
   Ph:(04) 471 9197 Fax:(04) 472 4169

Below is a letter   (already written for your convenience) to send by either fax or mail to Don Brash and Paul Hutchison.  Please copy and paste this letter into word  (or any software you use), then edit if you wish and print for sending .  
Address to Parliament Buildings, PO Box 18888, Wellington -
no stamp required.   Fax numbers as above.

Dear Drs Brash and Hutchison

I have been following the Government proposal to create a Trans Tasman Therapeutic Goods Agency which would give the power to control all therapeutic products, including natural health products, medical devices and pharmaceuticals to an Australian based agency.

Until now I have been glad to hear of National's opposition to this proposal but recently have heard that despite its statements against the Joint Agency, National is considering supporting the enabling legislation. It has been shown the TTTGA will bring with it a staggering increase in compliance costs, the death of many New Zealand businesses and give a commercial advantage to their Australian counterparts.

You should know that over 2 million New Zealanders use natural health products and also this industry is predominantly made up of small to medium local enterprises. By risking the local industry you are risking the support of many New Zealanders like myself.

Natural Health Products must NOT be treated like pharmaceuticals or regulated under the same body as them.

Natural health products simply do not have the same risk as pharmaceuticals.

They need to be regulated as the separate industry that they are and that regulation MUST be based in, and controlled by, New Zealand.

The proposals have already been shown to achieve nothing in the way of increased public safety

Yours sincerely, 

Kind Regards
Dave Sloan
NZ Health Trust

Urgent Support

Last week it was announced that the proposed agency is now not likely to start until July 2006 but maybe sooner. This means that the Government has been forced to delay this project by up to 12 months from original start date which was to have been July this year. This delay has come about due to the intense opposition to the proposal and should be seen by us all as a sign of the impact we have had.

The Government has simply not been able to muster the political support to have the necessary legislation passed so far and this has forced them to delay the project.

We also know that the Government is now focused on making a significant push aimed at getting support from other parties. To this end recently the Minister of Health arranged a private meeting in her offices with a small number of companies in the Natural Health sector. Notably this meeting included representatives from large companies like Healtheries, Nutralife and Alaron but excluded the NZ Health Trust or any of the companies that, like us, have been strong in opposing the joint agency. The purpose of this meeting, we understand, was to show representatives of the opposition parties that the Government had "industry backing" for the proposal. Why would large companies support the restrictive TGA proposal read more.

The New Zealand Health Trust became aware of the meeting several days before it was held and made it clear to the Minister and other MP's that the meeting only involved those the Minister knew would support her and deliberately excluded anyone in opposition.

We made it clear that it did not reflect the views of the industry as a whole, or probably even a majority of the industry.

The meeting did make it clear to us however which companies are supporting the proposal and re-enforced how the Government will try and deceive other MP's into thinking this proposal has the support of the NZ industry and consumers. NZ Govt press release link

These recent events have once again highlighted just how important it is that we can show the MP's the extent of the opposition. We are hearing from many of you of your views and the cards and email have been effective however we need to show the MP's just how far the opposition goes to avoid your views getting ignored in preference to the views of those who are saying what the Minister wants to hear.

We would like all of you who support what we have been doing in opposing the Australian pharmaceutical regulators taking over our natural health industry, to go to this link http://www.nzhealthtrust.co.nz/poll.php 
you will be able to complete a form that records your opposition to this proposal.  We need a large number of supporters to prevent a few large companies dominating this issue.

We want to hear from you, as consumers and those involved in the industry, directly. We are aware that there are a limited few natural health industry groups who no longer represent the views of their members and are becoming dominated by these same large companies who want the merger with Australia to go ahead.

Media Release 26 October 2004 For immediate use

Just how close should Australia & New Zealand be?

CER under the microscope at Sydney Health Conference

Both the New Zealand and Australian governments will face a public backlash, if they continue to 'merge by stealth' without the express approval of the public, says a leading New Zealand lawyer.

Amy Adams - spokesperson for the New Zealand Health trust - was in Sydney to give a presentation at the 14 th National Health Summit on the pitfalls of the Trans Tasman Agency proposed to regulate natural health products.

"The current proposal is one of harmonisation, not mutual recognition," Ms Adams said. " Instead of the two countries recognising and respecting other, as was the agreed basis of The agreement on Closer Economic Relations (CER), Australia has demanded that New Zealand adopt its system or face a trade barrier for our goods."

"I know for a fact that our MP's are being told that this is critical to the relationship between our two countries, and if we don't tow the line, CER is. if not dead ..certainly on life support."

Ms Adams believes that this type of bullying by Australia is not only against the spirit of CER, but illegal under World Trade organisations rules. "Frankly, it looks very much as though Australia ignores CER when it suits, but insists on it when Australia will win at NZ's expense," she told delegates to the conference.

"We strongly believe that the New Zealand public has not had a chance to consider the implications of this and other 'incremental' changes to our constitutional law system."

Ms Adams said she was NOT opposed to moving closer to Australia if the NZ public decided it was a good idea. "But both Governments should be on notice that New Zealanders will not put up with it being imposed by stealth."

For more information please contact:

Australia : New Zealand

Dawn Wills Ph 0416 293 349 Belinda Milnes Ph 021 802-447

Protecting Trans-tasman Competition & Consumers: Productivity Commission Proposes Improvements

Media Release

This media release and key points were issued with the draft research report, Australia New Zealand Competition and Consumer Protection Regimes , on 20 October 2004.

Enhanced cooperation between Australian and New Zealand competition and consumer protection regulators is proposed in a Productivity Commission draft research report. The Commission has concluded that more radical reform of the Australian and New Zealand regimes is not warranted at the present time.

The Commission found that the Australian and New Zealand regimes are already highly harmonised and are not generally impeding businesses operating in the Australasian market.

The Commission considered that radical solutions - such as identical laws and a single Australasian regulator - would have high implementation costs, would require changes to the operation of existing national regimes and would deliver only modest benefits. Presiding Commissioner Tony Hinton said "radical change would not be worthwhile given the small benefits such changes would deliver and the large costs of implementation".

In the Commission's view, the effectiveness of the competition and consumer protection regimes in dealing with matters in an Australasian market could be improved by:

• providing for the regulators to be able to use their investigative powers to assist the regulator in the other country
  
  
• enhancing the powers of the Australian and New Zealand regulators to share information
  
  
• building safeguards into the regimes of each country to ensure that shared confidential information remains protected from unauthorised disclosure.

Tony Hinton said "these changes would be consistent with the current policy of pursuing harmonisation and building a foundation for the goal of establishing a single economic market".

This is a draft research report prepared for further consultation and input prior to the Commission finalising the report to Australian and New Zealand Governments in December 2004.

Submissions from interested parties on the draft research report are being sought by mid November 2004.

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