PROTESTORS RALLY AGAINST REGULATION OF HEALTH PRODUCTS HEALTH-REGULATION-RALLY
766 words Dec 12th 2006 4:00pm Politics/Politics

Wellington, Dec 12 NZPA - About 100 people rallied at Parliament today to
protest Government moves to set up a trans-Tasman agency to regulate
therapeutic products.

The Government has struggled for years to muster support to ratify a treaty
with Australia setting up the regulator, but recently won the backing of
United Future and NZ First to get legislation past its first reading to a
select committee for consideration.

Therapeutic products to be regulated by the joint agency include medicines,
medical devices, and complementary healthcare products.

However many producers of complimentary medicines say a tighter regulatory
regime would impose big and unnecessary costs.

Protesters today communicated that view to numerous MPs who attended their
rally.
Natural Health Labs director Mike Cushman told NZPA the proposed changes
would impose about $500,000 in costs on his business, which manufactures the
"Clinicians" range of vitamins.

Most companies in the sector were small -- employing less than five workers
-- and tighter regulation would put many out of business.

He said there were few problems with complimentary medicines manufactured in
New Zealand and imposing "pharmaceutical-level" controls were unnecessary
and would limit consumer choice.

Green MP Sue Kedgley told protestors the legislation was "sinister" and
would cede regulatory control of New Zealand's industry to Australia.

The regulating agency would be based in Australia and would be headed and
staffed by Australians who would have powers to impose new regulations
without any kind of parliamentary vote, she said.

National, Act and the Maori Party also oppose the legislation.
Ms Kedgley said the bill only had enough support to pass its first reading
because NZ First leader Winston Peters had reversed his party's opposition
to the bill.

But a fired up Mr Peters told the rally NZ First had won significant
concessions, including New Zealand and Australia having equal say on the
regulations.

Under previous drafts New Zealand would have only had one vote, while
Australia would have had one for each of its states and territories.

Under pressure from hecklers who called out "traitor", Mr Peters said some
form of regulation was necessary to weed out "snake oil merchants" making
outrageous health claims about their products.

Having a strong regulatory framework would also enable local producers to
export their goods into other markets.
NZ First would make a final decision on which way they would vote after
public submissions to Parliament's local government and administration
select committee, he said.

State Services Minister Annette King, who is overseeing the legislation,
later told reporters the protesters were a vocal minority.

Companies which manufactured 80 percent of the locally made products
supported the move which would weed out rogue traders and make their
products more marketable overseas.

"They want their products to be safe. They don't want New Zealanders to buy
a product and then find out it's got grass clipping in it, or lead, or
viagra, which is some of the things we've found in some complementary
medicines in New Zealand over the last few years."

Ms King said the regulations had not stifled growth in the sector in
Australia.
The Government had agreed to pay half the cost of regulation and the new
rules would be phased in over five years.
United Future leader Peter Dunne said he was supporting the Therapeutic
Products and Medicines Bill to select committee so all the arguments for and
against could be put on the table, but his party's MPs were reserving their
final decision.

Prime Minister Helen Clark yesterday said if the bill was to fail it would
raise questions about how further talks on regulatory integration with
Australia could take place in the future.

NZPA PAR gf ob

THERAPEUTICS BILL PASSED FIRST READING IRN-RALLY-PAREGIMES 145 words Dec 12th 2006 6:10pm Politics/Politics

Therapeutics Medicine Bill passed first reading in Parliament by 61 votes to 60; National's Tony Ryall says it will harm NZ business

Parliament has passed the first reading of the Therapeutics Medicine Bill by the narrowest of margins.
It has scraped through by 61 votes to 60.
National Party Health spokesman Tony Ryall says the regulation will be costly and restrictive and will harm New Zealand businesses.

He says there should be regulation of therapeutic products, but not such a bureaucratic regime.
Natural Health Laboratories executive director Michael Cushman is also warning of dire consequences if the Bill is passed into law. He says the legislation will drive small companies out of business and lead to a loss of innovation.

He says over 95 percent of New Zealand companies employ fewer than six people and the cost imposed by the regulation will simply kill them.

GREENS ACCUSED OF DECEIVING PUBLIC IRN-RALLY-PACONTROLS 124 words Dec 13th 2006 5:30am Politics/Politics

State Services Minister Annette King claims Greens spreading disinformation over claims about Therapeutics Medicine Bill

The Green Party is being accused of deceiving the public over The Therapeutics Medicine Bill.
The proposed legislation seeks to create a joint trans-Tasman scheme for the regulation of therapeutic products, such as medicines, medical devices and dietary supplements.

State Services Minister Annette King is accusing Green MP Sue Kedgley of spreading disinformation with her claims the legislation will see Australia calling all the shots. She says the new authority would be based in both New Zealand and Australia with head offices in Wellington and Canberra.

Parliament has voted 61 votes to 60 in favour of the legislation and the bill will now go to the Select Committee stage.

BILL GOES TO SELECT COMMITTEE FOR SCRUTINY HEALTH-REGULATION-D/L 927 words Dec 13th 2006 5:01am Politics/Politics

Wellington, Dec 13 NZPA - New Zealand First says it gained concessions before agreeing to help send a bill setting up a new trans-Tasman regulatory regime for medicines, medical devices and complementary health products to a select committee for scrutiny.

Under the new regime, a joint Australia/New Zealand agency will regulate therapeutic products.
Legislation on the new regulatory scheme was debated in Parliament yesterday, after about 100 people rallied on Parliament's grounds to protest the Government's moves to set up the regime.

Many producers of complementary medicines have complained the tighter regulatory regime will impose large costs on their businesses, with some saying they will face bills of many thousands of dollars.

Natural Health Labs director Mike Cushman told NZPA the proposed changes would impose about $500,000 in costs on his business, which manufactures the "Clinicians" range of vitamins.

Most companies in the sector were small -- employing less than five workers -- and tighter regulation would put many out of business.

He said there were few problems with complementary medicines manufactured in New Zealand and imposing "pharmaceutical-level" controls were unnecessary and would limit consumer choice.

New Zealand First had previously opposed the legislation but its leader Winston Peters said it had won significant concessions, including New Zealand and Australia having equal say on the regulations.

Under previous drafts New Zealand would have only had one vote, while Australia would have had one for each of its states and territories.

Under pressure from hecklers at the protest rally who called out "traitor", Mr Peters said some form of regulation was necessary to weed out "snake oil merchants" making outrageous health claims about their products.

He lobbied to get a 50 percent subsidy on the cost of registering products under the new regime.
United Future leader Peter Dunne said there were issues that needed to be "teased out" during the select committee stage which was why his party was supporting the bill's first reading.

But National health spokesman Tony Ryall said Food Safety Minister Annette King had "bought off" United Future and NZ First support with the 50 percent subsidy. That had been the only way to garner enough parliamentary support to progress the legislation, he said.

Ms King yesterday said the joint regulatory scheme would "cover the regulation of the manufacture, supply, import, export and promotion of therapeutic products", as well as set standards over the quality and performance as well as post-market monitoring of therapeutic products.

She said responsibility for regulating aspects of the therapeutic products would be transferred from Medsafe New Zealand to a new agency, the Australia/New Zealand Therapeutic Products Authority.

Ms King said there had been uninformed and misleading rhetoric about the place of complementary medicines and medical devices in the scheme.

Regulation of medical devices and complementary medicines in New Zealand was minimal.
Complementary medicines were popular with many consumers and often perceived to be a safe and natural alternative to conventional medicine.

"But they are not risk free," Ms King said.
They could include harmful ingredients, adulterated products, there could be poor quality control during manufacture, interactions with other medicines -- for instance, interactions between St John's Wort and several prescription medicines -- and inadequate information to guide safe use.

Ms King told reporters after the rally that the protesters were a vocal minority.
Companies which manufactured 80 percent of the locally made products supported the move which would weed out rogue traders and make their products more marketable overseas.

"They want their products to be safe. They don't want New Zealanders to buy a product and then find out it's got grass clipping in it, or lead, or viagra, which is some of the things we've found in some complementary medicines in New Zealand over the last few years."

Green MP Sue Kedgley kept up her fight against the trans-Tasman agency, saying New Zealand was transferring power over dietary supplements, medicines and medical devices to an "offshore entity".

She told the protesters the legislation was "sinister" and would cede regulatory control of New Zealand's industry to Australia.

The regulating agency would be based in Australia and would be headed and staffed by Australians who would have powers to impose new regulations without any kind of parliamentary vote, she said.

The Therapeutic Products and Medicines Bill was sent to a select committee for scrutiny on a vote of 61 to 60. Labour, NZ First, United Future and the Progressive Party voted for the bill while National, the Greens, the Maori Party and ACT voted against it.

NZPA PAR sje ob

Winston looses the plot at Natural Health Products protest at Parliament

There were dramatic scenes outside Parliament today as NZ First leader Winston Peters was verbally attacked and shouted down by a group of enraged people at a protest rally.

Several hundred natural health product supporters met to protest the first reading of the Therapeutic Products and Medicines Bill, which would see control of the sector given to an Australian agency.

Despite telling the media 6 weeks ago that he had “stopped” the Bill, Mr Peters and New Zealand First today voted with the Government to send the Bill to Select Committee.

Amy Adams, spokesperson for the NZ Health Trust pointed out the issue had already been to Select Committee twice, and had been thoroughly rejected on both occasions.

“Everyone except the Government acknowledges that the Bill will be bad for New Zealand. It would devastate the local industry, push prices up for many products while seeing other products removed from the shelves.”

At the protest the Maori Party announced its unconditional opposition to the Bill, to the crowd’s delight, but Mr Peters was booed, shouted down and finally had to be removed from the microphone.

“Winston knows he has broken his word, and getting angry with the media and the public attending the rally was not constructive,” Mrs Adams said.

The Hon Tony Ryall representing National, Sue Kedgley form the Greens and Hone Harawira from the Maori Party addressed the crowd, as did Mike Cushman from Natural Health Laboratories NZ about the disastrous effect the Bill would have on his business.

ENDS

12 December 2006 Media Statement

Oral health the issue? Let's talk fluoridation

New Zealanders voicing genuinely held concerns about diet drinks and tooth decay should join the Labour-led government's call for the expansion of fluoridated water supplies, Health Minister Pete Hodgson said today. read full article...
http://www.scoop.co.nz/stories/PA0612/S00226.htm

NEW ZEALAND ASSOCIATION OF CHINESE MEDICAL HERBALISTS - NZACMH

MEDIA RELEASE

Kiwis will suffer in new bill that bans Chinese Medicine

Tuesday 12 Dec 2006

Today the ANZTPA bill will have it's first reading in parliament. These new laws aim to regulate the natural health products industry. Instead they favour the commercial interests of the establishment and aim to restrict and outlaw much of the flourishing complementary health industry. With our failing health system, many kiwis are turning to centuries old medicine and paying privately for their healthcare. This new system will outlaw many herbal products currently in use, despite no deaths and very few adverse reactions. As a result many kiwis will be driven back to the sinking ship of the public health system. read full story...
http://www.scoop.co.nz/stories/PO0612/S00152.htm

Medicine bill axes proposal to ban TV ads

A parliamentary bill, tabled this week, has raised concern among groups fearing it will damage New Zealand's natural health products industry.

The proposed Therapeutic Products and Medicines Bill would set up a trans-Tasman regulatory regime for all medicines, medical devices and alternative health products.

It would also establish the joint Australia New Zealand Therapeutic Products Authority.

The bill, expected to have its first reading next week, had been expected to curtail the advertising of prescription medicines.

However, widespread political opposition has forced Labour to scrap any attempt at a ban. read full story...

Hon Tony Ryall
National Party Health Spokesman

07 December 2006

Therapeutic Bill a bureaucratic nightmare

National’s Health spokesman, Tony Ryall, is attacking Labour’s decision to push ahead with a trans-Tasman agency to regulate natural healthcare products.

Mr Ryall’s commenting after the tabling of the Therapeutic Products and Medicines Bill. National is opposing the Bill.
"We are not prepared to jeopardise the viability of hundreds of small businesses nor the choices of thousands of consumers. This regime will be costly, restrictive and is unnecessary.

"It's a move that's going to cost industry and consumers. The Australian natural health products industry is one of the most highly regulated in the world, and applying its rules here will only serve to increase the cost of products, reduce consumer choice and hurt many businesses.

"There should be regulation of natural health products but not this bureaucratic nightmare.
“The fact that the Labour Government has had to offer a 50% subsidy to garner parliamentary support proves this regime is too expensive."

Ends

Inquiries:      Tony Ryall              021 953 024

Government sneaks Bill into House to avoid public backlash

Despite unprecedented political opposition, the Government has forged ahead with the Therapeutic Products and Medicines Bill, sneaking it into the House without any of the usual fanfare.

In 2003 Minister Annette King signed a Treaty with Australia agreeing to hand control of the natural health products sector over to an Australian regulatory body, however she needs to pass enabling legislation in New Zealand.

Twice the Bill has been thrown out by select committees, but the Government is determined to ram it through Parliament, said consumer group the New Zealand Health Trust.

read full story
http://www.scoop.co.nz/stories/PO0612/S00066.htm

New Zealand First's reputation will be in tatters on Tuesday if Winston Peters reneges on his public commitment to stop the establishment of a trans-Tasman regulatory agency that includes dietary supplements.

Just over a month ago Peters promised on Radio New Zealand: 'For those people that believe in natural medicines, they (NZ First) have stopped the therapeutic bill that would have included all natural medicines being run by a trans Tasman agency. That's stopped.'

"However, the Greens understand that far from stopping the bill, New Zealand First will be supporting it when it is introduced into Parliament next Tuesday," Green Party Health Spokesperson Sue Kedgley says. read full story...
http://www.scoop.co.nz/stories/PA0612/S00111.htm

The government has tonight (Tuesday 5 Dec 06) tabled the ANZTPA bill with absolutely no announcement or advance warning.

The Bill is 494 pages and Natural Products are definitely included.

http://www.parliament.nz/en-NZ/PB/Legislation/Bills/1/5/8/158f6594b0e74acf89fee18dd11c0f92.htm

Focus on Politics - Radio New Zealand

Taken from Checkpoint on 20 Oct 2006

New Zealand First is languishing in the polls and wants more support from young people. Winston explains some of the good things that NZ First has achieved which includes ;

winston Short 55 sec version

Full Version

From Checkpoint on 20 Oct 06, click on Focus on Politics.
If you have Windows Media Player you should be able to listen to the audio.

http://www.radionz.co.nz

Slide the time bar along to 9-40 mins finishes at 9-55 mins.

Proposal that Herbal Medicine become a regulated profession under the Health Practitioners Competence Assurance Act 2003 Consultation document

http://www.moh.govt.nz/moh.nsf/by+unid/8FACBCD05B975D78CC257228007335DA?Open

Australian Govt launches alternative medicine study
Herbal and other alternative medicines are about to be put to the test, with the federal government committing $5 million to determine whether they really work.

Australians spend about $1 billion each year on complementary medicines including vitamins, homeopathic medicines and traditional Asian and indigenous medicines.

http://www.theage.com.au/news/National/Govt-launches-alternative-medicine-study/2006/11/23/1163871541540.html

Americans Surprised, Concerned that 90% of Flu Shots Contain Mercury

• Health Officials' Aggressive Flu Shot Campaign May Disregard Safety, According to Survey of 9,000 Americans
  74 Percent of Respondents Unaware Flu Shots Contain Mercury, 78 Percent Disagree with CDC About Vaccinating Pregnant Women and Children
  PRNewswire, Nov 13, 2006
  Straight to the Source

PORTLAND, Ore., Nov. 13 /PRNewswire/ -- As health officials step up their effort to vaccinate Americans against the flu, a new survey suggests serious concerns over the toxin mercury, an ingredient in over 90 percent of this season's flu shot supply. PutChildrenFirst.org, a parent-led organization advocating vaccine safety, commissioned a survey of over 9,000 Americans to learn their plans for getting flu shots, their knowledge of its ingredients, and who they hold responsible for making sure vaccines are safe.

The survey revealed that the overwhelming majority of Americans were unaware that most flu shots contain mercury and that they would refuse a shot with mercury.

Nutricide - Criminalizing Natural Health, Vitamins, and Herbs

The Codex Alimentarius is a threat to the freedom of people to choose natural healing and alternative medicine and nutrition.

http://video.google.com/videoplay?docid=-5266884912495233634&q=nutricide

This is a Video from “Friends of Freedom” one of the World coalition members in the US about Codex. Its 40 mins long but worthwhile viewing

Exported Controversial Vaccine

A preview of a documentary that aired on Norwegian TV this morning (NZ time)

By Connie Barr, Karen Aarre and Kjell Persen
TV2.no Reporters
Translation of article from: http://pub.tv2.no/TV2/magasiner/dokument2/article771764.ece

At the same time while Norwegian authorities were paying compensation to vaccine victims, the same vaccine was exported to New Zealand and used on small kids. To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment, says Jan Helge Solbakk, professor in medical ethics.

1988 started the largest experiment ever conducted on Norwegian population. 180,000 school teenagers were used as test subjects in the largest Norwegian vaccine trial ever. It lasted from 1988 to 1991.

Norwegian Institute for Public Health was testing it's new vaccine against meningococcus b, dangerous bacteria that kills 30 people every year in Norway.

The information brochure given to teenagers states: " it is unlikely to expect serious complications ", while the information submitted to the Norwegian Parliament states: " serious side effects can not be excluded " during the experiment.

Jan Helge Solbakk, professor of medical ethics - Foto: TV 2

Jan Helge Solbakk, professor of medical ethics, was working on the ethical sides of the trial. He claims: "project leaders knew that trial subjects may suffer serious complications during the trial, statistically speaking."

"Trial subjects were not properly informed about the possibility of serious side effects during the trial. We encouraged the project leaders, during an open meeting, to do it in a better way, informative way" says Solbakk to Dokument 2.

- 512 side effects were reported during the vaccine trial.
- 14 were considered serious.
- 5 school kids developed serious neurological diseases.

During the second trial, involving 53,000 kids, 10 serious side effects were reported, while 1 child developed serious neurological disease.

Worried about the side effects

Hans Cato Guldberg, professor of medicine, was a member of a committee that was to evaluate side effects during the experiment.  He was worried.

"Some time after the experiment was over, I came to a conclusion that there were serious side effects to this vaccine.  And, the number was relatively high.  I was worried.  At the same time, I felt that project leaders were trying to tone down the danger of vaccine, said Guldberg.

Results of the vaccine trial were compiled 1991.  Vaccine was providing protection in 57% of cases.  That was not enough to add it to the Norwegian vaccination program.  As meningococcus b epidemic was dying out, vaccine was never used in Norway the way it was meant.

Foto: TV 2

After the request from the World Health Organization (WHO), vaccine was exported to New Zealand, during 2001.  Using the same technology and the same methodology from 1980s, researchers from the Norwegian Institute of Public Health tailored a new vaccine for New Zealand.  The multi-national pharmaceutical company Chiron was awarded rights to mass produce the vaccine.

Usually, vaccine is supposed to pass different tests before it is approved for mass use on population.  But this vaccine was tested in a record short time.  Phase III trials were totally dropped.  Rare side effects are often not discovered before the phase III trials.  Phase III trials are randomized, placebo controlled trials. Instead of testing this new vaccine through a new phase III trial, safety data and affectivity data were just taken from the Norwegian vaccine and assumed valid for the New Zealand vaccine.  Because safety data of this vaccine was incomplete, the vaccine was not officially approved on New Zealand.  Instead, mass vaccination of 1.1 million New Zealand kids started with a temporary approval.

Breach of the international research ethics

In New Zealand, the Norwegian vaccine was used as guarantee that the New Zealand vaccine is safe and effective. It was the Norwegian Institute of Public Health that was the guarantor.

"First: Norwegian vaccine was not safe! Second, it is a serious overstatement to say that vaccine is effective. Third: it is against international regulations and against research ethics to start to vaccinate small children on New Zealand with a vaccine that was tested on a different group of people, Norwegian school kids. To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment," says Jan Helge Solbakk, professor in medical ethics."

Quote: "Some time after the experiment was over, I came to a conclusion that there were serious side effects to this vaccine. And, the number was relatively high. I was worried. At the same time, I felt that project leaders were trying to tone down the danger of vaccine."

Hans Cato Guldberg, professor of medicine, was a member of a committee that was to evaluate side effects during the experiment.

Natural medicines – the safest way to avoid death

A report just released by the Acting Chair of the Coroner’s Council has shown natural medicines have the lowest fatality rate of all medical treatments in this country.

Despite extensive research, coroner Dr Wallace Bain found no deaths have occurred in this country due to natural medicines such as vitamins, minerals and herbal products.
Click here for the PDF.

Australia inquires into GPs’ sale of complementary medicines
from bmj.com news roundup
An ethical debate has arisen among doctors in Australia after the federal government
announced plans to investigate the sale of complementary medicines by GPs.
click here for the PDF

Vaccination - The Hidden Truth (1998) - on Google Video

http://video.google.com/videoplay?docid=8610554679207090010&q=vaccination

Related Website: www.vaccination.inoz.com

Health Canada betrayed trust
Canadians needlessly suffered and died as a result of decision
Calgary Sun,August 20, 2006
By Licia Corbella

If it's true that Health Canada's mandate is to protect the health of Canadians -- as its name suggests -- then the federal government needs to call an inquiry into the disgraceful and deadly actions of this agency.
read PDF article

NDPSC FORESHADOWS DECISION TO SCHEDULE GLUCOSAMINE Sulfate Potassium Chloride Complex - S4 (Prescription only)
 
The National Poisons and Drugs Scheduling Committee (NDPSC) last Friday foreshadowed a decision to schedule as prescription only Glucosamine Sulfate Potassium Chloride Complex (D-Glucosamine Sulfate -2KC1) products based on the potential for inadvertent overdosing due to the potassium content. The primary basis for the scheduling proposal is the overdose death of a child from ingesting of slow release potassium chloride tablets.

CHC is extremely concerned about the potential impact of this scheduling proposal on the complementary healthcare industry, should it be confirmed. Immediate action has been taken to address this enormous threat to our members and many have been contacted to assist with the gathering of information to establish our case to not proceed with the foreshadowed scheduling.

Discussions have been held with TGA and we have provided data to assist them in addressing the issues raised by the scheduling committee. The TGA have indicated that they share our concerns with this foreshadowed scheduling decision.

Please be assured that we are doing everything possible to achieve a sensible outcome from the committee. As more information comes available we will continue to update members.

TRANSTASMAN AGENCY FOR MEDICINES ABOUT MUCH MORE THAN PILLS
Aug 9th 2006 1:30am Newspapers/Nz Herald

On page: C04
HERE'S a way to get up an Aussie nose: Junk the proposed joint therapeutics agency. Which would probably get up our own nose by setting back progress towards the single economic market (SEM).

read PDF article

Judgment won today in the Alberta courts against Health Canada
28 July 2006

This is a major victory in Canada for the use of nutritional products. The trial was won on the basis of a necessity defense and due diligence.
Read PDF article

We have also attached an article found about the judgment on the CBC National News site..
Read PDF article

POLITICS: Health regulator mired in MMP mud
The Independent Financial Review - 05 JUL 2006 : Page 005

DONOGHUE TIM

FORMER Health Minister Annette King's planned trans-Tasman medical safety agency appears destined to founder on the rocks of MMP politics.

The Australia New Zealand Therapeutic Products Authority, costing an estimated $A73 million annually, is due to come into force with the passing of legislation later this year.

But Green Party MP Sue Kedgley is determined to ensure King, the minister responsible for setting up the authority, doesn't get the empowering law through the House.

The agency would merge Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe).

Products to be regulated include prescription and non- prescription medicines, complementary medicines, medical devices, blood and blood components and tissue and cellular therapies.

Kedgley, who last month helped sink the government's attempt to include working farm dogs in microchipping law, says the new agency is a dead duck.

"They've already wasted $6 million of taxpayers' money on something which won't get off the ground politically here," said Kedgley, Parliament's health select committee chairperson.

The MMP odds are stacking up in Kedgley's favour with Tony Ryall, for National, Barbara Stewart, for New Zealand First and Heather Roy, for ACT, stating their parties will oppose introduction of the legislation.

United Future and the Maori Party are in talks with King and showing signs of support for the agency. But even with their support, the measure is unlikely to be passed.

King said New Zealand could kiss goodbye to working co-operatively with Australia on other similar regulatory bodies if Parliament rejected the proposition.

It was "very much in keeping," King said, with the 1983 Closer Economic Relations agreement and the Trans-Tasman Mutual Recognition Arrangement of 1996 - agreements seeking to remove regulatory barriers and facilitate trade between the two countries.

New Zealand would be required to pick up $A7.8 million of the annual running tab.
"It's a very good deal for us," King told The Independent Financial Review. "It's not one for the Nats to play fast and loose on. If they do, people will remember when it's their turn in government."

King found herself offside with the majority of the health select committee when she ploughed ahead with the joint agency idea, after the committee recommended in December 2003 she concentrate on establishing a stand-alone New Zealand agency.

King signed an agreement with the Australian government in spite of this opposition and that of business people such as Bill Bracks, who heads health company Comvita. He says TGA rules are applied to industry in Australia in a "petty, pedantic way" New Zealanders can do without.

A three-year transition period is proposed, during which:
* Manufacturers and sponsors must obtain product licences;
* Products must comply with all requirements of the joint scheme before product licences are granted;
and
* No re-evaluation of products approved under current regulatory requirements of either country.
HEALTH REGULATION
THE trans-Tasman health products authority has been designed to:
* Regulate "the quality, safety and efficacy or performance of therapeutic products in Australia and New Zealand"
Products covered:
* Prescription medicines, over-the- counter medicines, complementary medicines, medical devices and blood
Costs:
* NZ's estimated $7.8 million share of the total costs to be met from industry
* Some industry lobby groups have opposed the treaty for offshoring NZ decision-making, adding costs and potentially driving out some businesses

TIMELINE
SIX years' work towards a trans-Tasman health products regulator:
May 2006
Consultation begins on licensing, rules, fees and charges
Authority will now start "next year"
March 2006
Bills to be introduced to NZ and Australian Parliaments in July
May 2005
Australia and NZ agree on standards committee
February 2005
Agency will start "next year"
March 2004
Treaty to establish the agency introduced in both Parliaments
December 2003
Both countries sign treaty
March 2001
Health Minister Annette King announces NZ and Australia will consider joint agency
2000
Consultation on possible framework for agency

Cabinet paper reveals secret decision

Documents released under the Official Information Act to the Green Party reveal that the Government made a decision to veto mandatory country of origin labelling of food in secret, without any debate in Parliament or consultation with any parties in the House, MP Sue Kedgley says.

The government last year unilaterally pulled out of a joint food standard with Australia that would have required New Zealand to introduce mandatory country of origin labelling of food.

Cabinet papers, made public by Ms Kedgley, show that the Minister of Food Safety, at the time, Annette King, told the Cabinet Business Committee that in making its decision ‘consultation is not required with the government caucuses or other parties represented in Parliament’.

Most remarkably, the largest group of legislators in the country, the Labour Party caucus, were not even consulted when the Minister moved to introduce this rift into Trans-Tasman relations.

“This is breathtaking arrogance and complete disregard for democracy. It has all the hallmarks of Muldoonism, with the executive making decisions without any input from Parliament,” Ms Kedgley says.

“The decision as to whether or not there is mandatory country of origin labelling of our food is of vital interest to New Zealand consumers and to many MPs and parties in the House.

“Yet the Minister decided to ignore their views, and not to even consult with MPs, but to go ahead and make the decision in secret.

“She justified her decision by saying that there is no demand amongst New Zealanders and no consumer benefit from country of origin labelling. This is outrageous and completely contrary to independent research which found that 81 percent of New Zealanders want to know whether their food is imported or not.

“The Minister justified her decision by saying ‘it would set a precedent that would be unhelpful for New Zealand companies internationally’ and ‘would be a potentially trade restrictive and incompatible with our WTO obligations’.

“She doesn’t appear to have considered the interests of consumers in making this decision, only those of the meat and dairy lobbies,” Ms Kedgley says.

Ms Kedgley’s Consumer Right to Know Bill, being considered in the House today, would introduce mandatory country of origin labelling in New Zealand.

The Government has warned of damage to economic relations with Australia if National fails to support a long-planned transtasman drug agency. read full article... http://www.nzherald.co.nz/section/story.cfm?c_id=1&ObjectID=10388674

Aids HIV Bayer

Consultation over TGA rules a sham

Consultation by Medsafe over rules for the proposed Therapeutic Goods Agency is completely meaningless and an attempt to dupe the industry, according to consumer watchdog group the New Zealand Health Trust.

Medsafe is holding a top-secret consultation meeting on Monday afternoon with a small group of supporters to go over key points such as the proposed rules for natural health products and medical devices, and proposed fees and charges. Industry and consumer groups that have opposed Government’s plan have been denied entry to the meeting.

The Minister Annette King and officials are still trying to mobilize support for the proposed Trans-Tasman agency, despite firm opposition from all other political parties who are concerned it is not in New Zealand’s best interests.

“The Government knows it does not have the numbers to pass legislation to create this agency, however it is continuing with a costly programme of consultation and preparation for the new body,” said the NZHT’s Amy Adams.

“What’s more the consultation itself is meaningless, as the new agency‘s Managing Director could simply change the rules as soon as it was established,” Mrs Adams said.

Of enormous concern to the NZ Health Trust was the fact that the consumers, the local industry and New Zealand’s Parliament would have virtually no ability to influence the new agency once it was established.

“It’s time for the Minister Annette King to get realistic about the level of opposition to the proposed TGA and to re-open discussions with the industry and consumer groups about alternative ways to regulate this booming sector.”

Ends

REPORT BY OCEANIA HEALTH CONSULTING
January 2005 31 pages

REVIEW OF THE NEED FOR FURTHER REGULATION OF EXTEMPORANEOUS COMPOUNDING.

See item 2 The present legislative Framework in Australia and 2.1 Constitutional Limitations of the Therapeutic Goods Act, of this report showing a very real example of why the TGA is so keen for the trans tasman body - nothing to do with NZ - more about removing their constitutional inability to regulate sole traders and natural persons.

This report demonstrates that the TGA wants to extend its control to all Territories and states to cover natural people and reach into pharmacists and hospital controls, all of which are currently outside their domain.

(Only currently covers 3 of the 8 being NSW, Tasmania, but to a lesser degree Victoria)
Read the PDF by clicking here

27 March 2006

A schedule of consultation events to be held in both Australia and New Zealand was released today in the lead up to the establishment of the new Australia New Zealand Therapeutic Products Authority (ANZTPA).

ANZTPA will be a joint, trans-Tasman agency with responsibility for regulating therapeutic products across both countries. When established, it will replace Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). read full article click here

Plug pulled on single Tasman regulator

23.02.06
By Fran O'Sullivan, NZ Herald

The plan for a single regulator to supervise banks on both sides of the Tasman has fallen prey to New Zealand national interest sensitivities.

Australian Treasurer Peter Costello and Finance Minister Michael Cullen have instead announced both Governments will legislate to ensure their nations' banking supervisors collaborate on regulatory issues and avoid actions that could affect the financial stability of either country.

Former Pan Pharmaceuticals boss Jim Selim has launched a multi-million bid to sue the Therapeutic Goods Administration (TGA) for money he lost because of the complementary drugs manufacturer's collapse.

Lawyers for Mr Selim lodged several batches of documents with the Federal Court in Sydney on Monday, including a claim for about $140 million. read full article click here

TGA rent surges - industry to pay

Posted 23 January 2006

Occupation of its Canberra headquarters will cost the Therapeutic Goods Administration an extra $880,000 this year and the pharmaceutical industry will pay.

The considerable and unexpected hike follows a triennial rent review which lifted the annual cost of the TGA''s Symonston offices to $6.51 million, a boost of 15.6 per cent. The figure is made up of $4.65 million in pure rent plus $1.86 million for amortisation of the laboratory fit-out and other inclusions.

The regulator admitted the size of the increase was unexpected and had not been factored into its charging regime.

"This is the first market rent valuation undertaken since the sale of the complex in 2002," a spokesperson said. "The TGA had not anticipated a significant increase in its lease to arise from the market rent valuation and had not factored the increase into current fees and charges."

None-the-less, industry is expected to pick up the tab. "Rent costs comprise part of the normal operating costs of the TGA and are subject to full cost recovery from industry," the spokesperson said.

TGA HQ is owned by Cromwell TGA Managed Investment, a unit trust opreated by Brisbane-based company Cromwell Securities which bought it from the Commonwealth for $50.1 million in 2002. At the time of the purchase the unit holders were former Packer executive Trevor Kennedy, Ozemail founder Sean Howard and the current Liberal member for Wentworth, Malcolm Turnbull.

In September last year, the Australian Financial Review reported that Kennedy and Howard had sold out of the trust in a deal that netted them a $20 million profit and valued the building at around $80 million. By that time, Mr Turnbull had transferred his interest to his wife Lucy.

The newspaper added that Cromwell had sought to increase the rent to $7 million, a figure that was under review by an independent valuer.

The final rent increase was revealed to industry representatives at a TGA Industry Consultative Council meeting in November last year.

Be Wary of the ‘Instant Experts’

There is currently a significant amount of inaccurate and misleading information circulating on the internet about Codex and other related health freedom issues. Whilst some of the authors of this material claim to have carefully studied more than 16,000 pages of Codex documentation, the content of their articles and the nature of their proposed strategies strongly suggests otherwise. The following article may help you to sort the facts from the fiction. read full article click here

The 2005 meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) took place from 21-25 November, in Bonn, Germany, and was attended by 315 delegates representing 68 countries and 33 international organizations.

Any doubts as to whether or not Codex is concerned about its loss of trust and respect amongst consumers were immediately dispelled by the Committee's infamous Chairman, Dr. Rolf Grossklaus, who opened the meeting by stating that the Committee had to improve its public relations image. read full story click here

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