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The Agenda
Without Australians’ knowledge or consent the TGA gave multinational drug companies the power to expand into and monopolise Australian markets and shake out the Australian competition. This was done under the guise of protecting the Australian public health when there is nothing more than a trade war going on. As in most wars, people also die in trade wars, and another Australian has died as you read this because the TGA and its drug corporation allies are suppressing supplements and health information about the efficacy of supplements. This enables drug companies to destroy and take over the supplement market while continuing to profit from many particularly dangerous drugs that are known to kill and disable humans.
Remarkably, despite the shakeout, many small fry companies did survive and while the little Aussie battlers were still taking a breath, the TGA and its allies swung into action on an urgent agenda. The years 2003 to 2004 were distinguished by unprecedented changes to the structure of the regulator and the rising dominance of the pharmaceutically based health care industry. It was the beginning of both merging offshore into a massively powerful corporate structure – one that would whistle to the tune of CODEX.
In short, the regulator was becoming a corporation and being moved off shore into an international jurisdiction – out of the reach of litigation and away from the Australian and New Zealand voters – into CODEX jurisdiction. (45)
Part three will explore how this agenda was carried out.
Part Three
The Treaty Not Many Knew About
In the months after the Pan debacle, persons unknown to the Australian electorate drafted an international treaty between Australia and New Zealand called “Agreement Between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic products”, (known as the JTA treaty for short).
This treaty was signed on December 10, 2003 by the health Ministers of both countries without any public debate and without the consent or consultation with Australian or New Zealand Electors. The JTA treaty is intended to form the “legal” foundation for a massive new regulatory agency.
The JTA treaty was intended to come into full effect on July 1, 2005. IT has been postponed to a date on or anytime prior to July 1 2006 if Australians do not stop this enactment process by telling their Parliamentary representatives and the Australian Health Minister that they are NOT to pass any enactment legislation pertaining to activating this treaty. Many are already questioning whether any legislation that is passed by stealth has a legitimate force of law in a democracy, and that legislation passed in this manner is a legal nullity and subject to automatic repeal.
The “Agency” Not Many Knew About
The JTA treaty is intended to be the purported “legal” foundation upon which a monstrously powerful “world class” regulatory “agency” has been created. Known as the “Agency” or “the Trans-Tasman Joint agency” it would do away with the TGA as a statutory entity, which was at least theoretically accountable to Australian Electors. The new “agency” would also absorb Medsafe the New Zealand regulator within its tangled corporate structure. With those two entities nullified the newly born mammoth “Agency”, scheduled to come into effect on or before July 1, 2006 is in fact structurally an off shore corporate business set to be run by a chairman of the board, a managing director, two persons with “regulating experience” and a person with “broad experience in commercial matters”. This Agency potentially creates a corporate partnership between the regulator and the trans-national corporations, which removes it a further step from the Australian and New Zealand elector and into the direct jurisdiction of the World Health Organization global regulator CODEX. (18)
These drastic changes have been conducted in such a secret manner that even Dr. Robyn Napier the AMA representative said of it; “the process has largely occurred without the knowledge of the public.”
HARM-onizing Kiwi Cousins
Trans-Tasman harmonizing means to force the Australian “regulatory standards” onto New Zealand’s supplement industry which up until recently enjoyed relative prosperity and freedom. “Harmonization”, creates the same WTO global standards in each country that are vital to the interests of trans-national pharmaceutical corporations.
For several years now it seemed as though Australia had been the designated vitamin police in the South Pacific region. However, immediately after Pan was disposed of, extra plane loads of gray be-suited men from the TGA were flown across the Tasman at tax payer’s expense to do to the KIWI (43) industry what TGA was doing to the Australian supplement industry – making way for the big drug corporations. Like a squad of mafia hit men, the TGA visited upon New Zealand’s supplement industry its new “international standards in regulatory excellence” and sent their vitamin businesses to the wall as they “regulated” their way through Kiwi companies. New Zealanders did not appreciate Australian HARMonizing efforts, as their many websites and activists indicate. Australians, however, were not alerted by the mainstream media. They remained largely unaware of the issue while the TGA cooked up yet another scheme, the trans-Tasman advertising agency.
The Trans-Tasman Advertising Scheme Not Many Knew About
In mid 2003 the Pan carcass was barely cold but the TGA remained a hotbed of activity. With so much big business coming together under the JTA treaty and its “Trans-Tasman joint Agency”, TGA embarked on a new round of committees that ensured the panopoly of corporations would have a collective voice in the media to advertise their goods. New “standards” had to be urgently drafted up by the TGA and its pharmaceutical corporation partners that would come to be known as the “Therapeutic Products Advertising Code”.
To many Australian electors it might still seem unusual for its official regulator to collaborate with media moguls and drug executives and create an advertising agency, but that is what happened in mid 2003, when one of the first of a series of many consultation meetings took place with the “stakeholders”. The trans-Tasman advertising scheme had among its attending delegates representatives from Unilever, Johnson & Johnson, Pfizer, ReckitBenckiser, Procter and Gamble, and Roche. (19, 20). Later in the year a similar meeting was convened at the Sydney Masonic hall and attended by many delegates including from Eli Lilly, News Ltd, Boots, various advertising agencies, Faulding, Astra Zeneca, Baxter, Glaxo, Boehringer Inngelheim, Fairfax, Merk, Novartis, Schering Plough, Pfizer, Roche and of course who else but Wyeth. [Further explanatory note in reference number (21) ]
Dr. Robyn Napier of the AMA, normally an ultra conservative organization, stated in her submission to a Parliamentary committee on April 30, 2004; “the process is occurring against a backdrop of enormous pressure on a number of fronts, including: (pressure) from pharmaceutical companies...to open up direct consumer advertising. To down schedule medicines to categories where direct consumer advertising is possible.” (24) (The AMA was unhappy about this but did not cite patient safety concerns such as the new advertising code allowing a confused grandparent or a vulnerable teenager to purchase prescription drugs directly from the chemist.)
It seemed the trans-national pharmaceutical corporations were finally able to write their own advertising “code of ethics” allowing them to advertise their prescription drugs over the media. This necessitated that prescription drugs would be down regulated to become over the counter drugs. At the same time the code was also drafted in such a way as to tighten up regulations on supplement advertising making it virtually impossible to even mention a positive health effect from a vitamin in public.
The Front Organisations
According to an inside industry source, the media advertising of the therapeutic products advertising code is managed by pharmaceutical front organizations such as ASMI, the Australian chapter of the Self Medication Industry which directly represents the interests of over a dozen trans-national pharmaceutical companies such as Pfizer, Merck, Roche, Glaxo and Wyeth (as well as a number of smaller companies).
Some time ago I noticed that a world wide dietary supplement trade organization called the Council for Responsible Nutrition (CRN) seemed to pop up regularly on Codex committees in Europe and it also wafted around the Aussie TGA. The CRN has chapters in most developed countries and takes a lead role in advising governments on issues such as nutritional supplements. It represents over 100 companies in the “dietary supplement industry”.
The international CRN’s membership includes multinational corporations such as: Eastman chemical company, BASF, Bayer corporation, Monsanto and the ever present Wyeth pharmaceutical company whose interests are represented by the organisation. (26,27,44)
The CODEX They Tell You Isn’t Real
The public constantly sends me information asking me to comment on it. Recently a flurry of official information updates have landed on my desk from the Complementary Healthcare Council (CHC), Mr. Khoury and from the TGA. Others such as Stephen Myers have written scathing articles disputing the information contained in this article. In the first paragraph of his article entitled “Codex, Cabals and conspiracies”, Mr. Myers claims there is no pharmaceutical influence in the TGA. Mr. Myers claims this when he is in fact a member of the “ TGA expert committee” along with the Vice President of Wyeth Drug company who sits on the same committee with Mr. Myers.
These updates and articles continue to be widely disseminated to multi level marketing groups, practitioners, manufacturers and the community despite the fact that they do not address the issues raised by this author’s article, but rather confuse or misrepresent data that is vital to the future of manufacturers, practitioners and the public alike.
In essence, the information releases allege: CODEX is only about food and not about supplements. The public is being ill informed about CODEX and confused by persons on the internet with “alarmist views” who “do not fully understand how Codex works”. It says the only Codex representative Australia has is from the fisheries department and he doesn’t make decisions about supplements, (only fish). And no one in Australia is sitting on any Codex committee and if they were they have nothing to do with vitamins and supplements. Only about food. Nothing about supplements… (29 ) In extra warnings in bold letters the updates urge all members to be cautious of CODEX information from the internet and other forums, claiming it may be “inaccurate” , “alarmist” and “ill informed” and the ramblings of conspiracy theorists.
I read the updates and “articles” and immediately suffer from a bad case of deja`vue. I could have sworn they were all written by one and the same person and merely recycled.
Most notably professional organizations have a duty of care to accurately inform at least 100,000 individuals in the supplement trade who depend on correct data for their livelihoods yet none have yet corrected their data despite the primary documents upon which this article is based now being available to the general public.
None of the releases or articles so far has tackled the true implications of the creation of an offshore corporate regulator in an international jurisdiction. For it would no longer matter whether supplements are regulated as drugs by the TGA since the TGA itself will be no longer in existence once the new regulator is moved out of this country and in the international jurisdiction of CODEX. The regulator would then have protection from legal liability in the event that its decisions caused damages to anyone. A perhaps understandable reason for the rush with which these changes have been pushed through and the absence of informed community debate.
AUSSIES Deep in CODEX
For many years now a few lucky Australians have been sent on a yearly trip to participate in the WHO CODEX committee in Europe. They are sent by their government, which officially denies Codex exists in the context of supplements. In November 2003 an Australian delegation landed in Bonn, Germany. The three day CODEX meeting was to be hosted by the Federal Republic of Germany.
Inside the stark German Government building the 25th session was being convened of the “CODEX COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES” by the authoritarian President and Chairman Herr Rolf Grossklaus. (There was no one from the Aussie fisheries department present in the Australian delegation.) The session was well attended by 225 delegates and advisors representing 48 member countries, including Australia and representatives from 29 organisations and trans-national corporations.
Herr Toepner from the German Federal Ministry opened the meeting with a short speech reminding the delegates of the purpose of the Codex committee; “to protect the health of consumers, to ensure ‘fair trade practices’ and the committee’s important responsibilities under the WTO”. (WTO is the global trade police ensuring trade barriers fall and local competition is leveled so that global corporations can take over national markets, in the name of “world class regulatory standards” and “fair trade practices”.)
Herr Toepner apparently stressed the same message given to the delegates at TGA/FSANZ head quarters, for they made an heroic effort to further the agenda of supplement restriction at the CODEX meeting. The CODEX committee Chairman was well pleased with their work. The funereal looking Herr Grossklaus gratefully accepted the Australian proposal to apply a “risk” analysis to nutritional supplements. The committee once again expressed its appreciation to the; “Delegation of Australia for its work in this important area and agreed that a ‘risk-based approach’ should be followed for the establishment of upper limits for nutrients,” as stated the 2003 CODEX minutes report. That meant the Committee was currently working on placing a restriction on world wide supplement consumers. The Australian delegation agreed with the Chairman that the next 2004 Codex “session should be kept informed of the progress achieved by WHO in order to facilitate its further work on vitamins and minerals.” (Author’s translation of meaning of this is in footnote 33)
Moreover, the CODEX observer from the Council for Responsible Nutrition agreed wholeheartedly - Probably much to the approval of its members Bayer, BASF, Monsanto and of course, Wyeth.
Among the CODEX participants that year, there were at least eleven multinational food and pharmaceutical companies including of course, Nestle and Roche. However, three delegations alone were from Wyeth.
The 2003 CODEX must have been considered such a success that the Australian delegate, Ms. Janine Lewis, Principal nutritionist, returned with another delegate the following year, Ms. Jane Allen, Senior nutritionist. Both are employees of the Food standards Australia and New Zealand FSANZ, a TGA related department which has joint committees with the TGA. The two departments share personnel, resources and curiously similar agendas. Interestingly, Val Johanson, formerly of CHC states in her bio that she; “held positions in the Australian Public Service as head of food standards at Federal level and she also established the Therapeutic Goods Administration’s surveillance unit, which she headed for almost four years. Positions currently held include; member of the Complementary Medicines Evaluation Committee, Chair of the Therapeutic Goods Advertising Code Council, Head of the International Herbal Regulatory Task Force of the International Alliance of Dietary Supplement Associations”.
There is much confusion deliberately generated by the regulator and its corporate partners to obscure the real agendas. Is Australia’s participation in CODEX about food or supplements? (therapeutic goods). The answer is both. This is what a law link had to say about the legal interface between foods and supplements after the changes to the Therapeutic Goods Act that was rammed through after Pan. “Food can now be a therapeutic good. The TGA is now able to designate food items as therapeutic goods. Previously, prescribed foods were not classified as therapeutic goods. Now, where a food product prescribed under the Australia and New Zealand Food Standards Code is designated by TGA as having therapeutic properties, the TGA may declare the product to be a therapeutic good, and therefore as subject to regulation under the Act.” (30) That includes vitamins and supplements which the TGA Act regards as medicines and drugs under the title of therapeutic goods.
The TGA has this to say about food being classed as medicine; “products which may fit within the definition of either a food or a medicine [supplements] are referred to a joint TGA/FOOD STANDARDS Australia New Zealand (FSANZ) committee which recommends whether the goods should be regulated as a therapeutic good or as food. This means TGA/FSANZ sends delegates to CODEX to get their orders about supplement regulations from overseas.
Conclusion
There is no more point to denying it. Australia is participating in CODEX. But that is not all that has occurred. Starting with Pan in 2003 the TGA and its trans-national pharmaceutical corporation allies waged a hostile take over of the Australian supplement industry. Later that year the Australian government signed a treaty that enabled the TGA and the pharmaceutical corporations to form what amounts to an offshore corporation. This would keep the voters at arms’ length and put the monstrous new “Agency” into the direct international jurisdiction of the WHO/WTO and CODEX. As a final blow Australian voters were not even privy to a new TGA amendment bill 2005 about to be tabled that caters to the needs of the drug corporations. All this because a trade war is raging. Bad news about drug deaths is getting out. Drug companies need to take over supplement market to offset their financial losses. The cost of this desperate corporate last stand may well be Democracy and Health Freedom of choice – but only if the community consents to it.
This is a time when the drug industry and our “regulators” are committing some stupid and desperate acts against human rights. Politicians don’t look good passing Parliamentary bills, acts and amendments in the dead of night – especially if they arose through improper influences. Remember their names, for it is they who are accountable for their ethics. And it is we who are accountable for the kind of society we have allowed others to create in our name.
In short, the argument whether the TGA regulates supplements as drugs is mute. The TGA will no longer exist this time next year. The plan was ingenious: Don’t bring CODEX to Australia – but deliver Australia to CODEX on the back of an international treaty.
Australians and New Zealanders who value their lives and freedom of choice can join and support Eve Hillary’s Health Freedom – CODEX campaign and attend the briefing seminars to stop the Trans Tasman Agency in the Pacific Region. For more information log onto: www.evehillary.org
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