TAKE ACTION - WHAT YOU NEED TO KNOW:
HEALTH FREEDOM…….THE WRITE WAY
Your rights to use and obtain dietary supplements are threatened and in peril through the proposed Trans Tasman Joint Agency with Australia to regulate medicines, medical devices and dietary supplements.The time has come when reactive measures are not enough.
We must be proactive!
We thought Medsafe (Ministry of Health)and Government had listened……….Now we find that the Joint Agency with Australia's TGA is proceeding even faster – without any further consultation with you, the consumer.
We need legislation in New Zealand for New Zealanders, not legislation imposed by Australia. We need our own New Zealand Act to preserv your right to have continued access to safe dietary supplements and labelling providing information about the benefits supplements provide.
WHAT YOU NEED TO DO:
If your rights to obtain and use dietary supplements of your choice are to be preserved, "harmonisation" of dietary supplement regulations with Australia must not proceed.You can make a difference if you care enough to do the following.
1. Telephone and write personal letters to your local Member of Parliament and to Ministers.
2. Telephone talk back radio such as Radio Pacific and Newstalk ZB.
3. Get as many of your friends and relatives as possible to do the same thing.
PLEASE DO THIS IMMEDIATELY
Use the information we have provided. Please do not copy it. Unless you individualise your letters they will lack effectiveness. A sample letter illustrating proper content follows. Also the names, addresses, telephone numbers and e-mail addresses of Members of Parliament you will need are included.
You do not need a stamp when writing to Members of Parliament in Wellington.
Please write to your local Member of Parliament and Ministers as detailed right now!
Remember: "The pen is mightier than the sword!"
KEY POINTS FOR LETTERS OR E-MAIL
To make your correspondence most effective, please include these key points:1. Be courteous and use proper titles:
The Right Honorable (name)
Dear Member of Parliament (name)
2. At the beginning of your correspondence, state a singular purpose for your communication:
e.g. Opposition to the proposed Trans Tasman Joint Agency for Dietary Suplements (TTTGA)
3. Make a call to action:
Please support a New Zealand Act to ensure my continued access to safe dietary supplements at a price I can afford. I object to paying higher prices to fund a hugely increased bureaucracy for little benefit to New Zealand.
4. Request a response:
I look forward to hearing from you soon.
5. Provide your complete return address and telephone number, fax number and e-mail address where possible.
SAMPLE LETTER TO MEMBER OF PARLIAMENT OR MINISTER
Your Name (print), Address, Phone, FaxYour e-mail address
The Right Honorable or Honorable
Minister of ………..
or Member of Parliament
Parliament Buildings
Wellington
Dear Mr/Mrs/Ms
DIETARY SUPPLEMENT REGULATIONS AND the AUSTRALIA NEW ZEALAND JOINT AGENCY
"Harmonisation" of dietary supplement legislation with Australia has been rejected by New Zealanders since 1992. I am concerned that a treaty establishing a joint agency with Australia is proceeding with restrictions already suggested to bring New Zealand into line with Australian TGA.
As a dietary supplement consumer, I ask you to vigorously oppose this treaty with Australia as it is detrimental to New Zealand's freedom of choice in health care. I seek your support for a solely New Zealand Act to protect and preserve my right to have access to dietary supplements of my choice and to information and labelling about the benefits dietary supplements provide.
I look forward to hearing from you soon.
Yours sincerely,
TELEPHONE PROCEDURES TO MEMBERS OF PARLIAMENT
Phone the electorate office of your member of parliament or their parliamentary office. They are busy and may need to phone you back.When making your telephone call ask for:
1. The Member of Parliament directly
If not available, ask for:
2. The Member of Parliament's secretary
Once you have their attention, tell them the purpose of your call. Express your desire for them to oppose "harmonisation" with Australia of dietary supplements and support the introduction of currently shelved Health Care and Therapeutic Products Bill to protect your right of access to dietary supplements and health care of your choice. Ask for the MP to contact you.
WHO AND HOW DO YOU MAKE CONTACT
See the list of names on our Contacts pageGOVERNMENT PROPOSAL FOR A JOINT TTTGA
On the 7th June 2002, the New Zealand Government released its proposal for a joint Australia-New Zealand Trans-Tasman Agency to regulate prescription, over-the-counter medicines, medical devices, and "complementary healthcare products" including herbal medicines and dietary supplements.PLEASE TELL YOUR FRIENDS!If you use, manufacture, import, distribute, or sell vitamins, minerals, homeopathic remedies, traditional remedies or other supplements - this proposal affects you. As a business owner, practitioner, or consumer of these products your health choices are at risk.
CFHC SUBMISSION TO MEDSAFE ON THE DISCUSSION PAPER 2ND AUGUST 2002
Part I: Introduction
The comments in this submission apply to the future regulation of dietary supplements (including vitamins, minerals, homoeopathics, amino acids and other nutritional supplements), whether they are regulated under a Joint Agency with Australia or under a New Zealand-only regime. Citizens for Health Choices (CFHC) expresses no opinion on how the proposal would affect other categories of products.
CFHC wants a sensible regime for dietary supplements that promotes the interests of New Zealand consumers and the industry that meets their needs.
Our goals for the outcome of this process are:
* We want consumers to have access to a wide range of safe dietary supplements.
* We dont't want costs to rise unnecessarily.
* We want consumers to have good information on what the products are used for.
* We want to make sure that the products are labelled accurately and are manufactured to the appropriate standard.
So this submission is made in a constructive vein, with a view to facilitating a sensible Dietary Supplements regime for New Zealand, whether or not that is achieved through harmonisation with Australia.
Because the systems for regulating dietary supplements are so different in New Zealand and Australia, it may be necessary for New Zealand to insist on excluding dietary supplements from co-regulation. The two systems have major philosophical differences and have been entrenched for many years, making it difficult to harmonise without creating major difficulties, especially in New Zealand.
The Discussion Paper emphasises common outcomes between Australia and New Zealand, as if commonality is a goal in itself. There is too little focus on good outcomes, and whether the proposal is good for New Zealand.
It is a real fear that the costly and, in our view, draconian rules that are in effect in Australia would dominate this Agency. This would limit consumer choice and damage many New Zealand businesses for no good reason.
Given that the states in Australia are not harmonised under the Therapeutic Goods Act, it is reasonable that New Zealand should reserve the same right for itself.
Nothing in this proposal should be taken as acceptance of the proposed Joint Agency. Although our comments are made constructively, in our view the current proposal is fundamentally flawed in three respects:
* Dietary supplements should logically be treated as a distinct category -i.e. separate both from medicines and food - as in most other countries.
* The proposed Agency has too much power to make rules, determine for itself the level of enforcement, and pass on costs without limit.
* The proposed governance arrangements damage New Zealand sovereignty and its citizens - rights to self-determination.
SUMMARY OF KEY POINTS
Insofar as it would affect dietary supplements, the Discussion Paper:
* provides insufficient evidence of a problem to justify the proposed regime.
*is fundamentally flawed in classifying dietary supplements as medicines, rather than in a separate category distinct both from medicines and food.
* proposes a regime that does not meet the Code of Good Regulatory Practice, nor the New Zealand Government's aim of reducing business compliance costs and red tape.
* proposes governance and accountability mechanisms that are dangerously flawed.
* while purporting to regulate products according to their risk, would regulate dietary supplements much more tightly than food - even though food is demonstrably more risky.
* gives the bureaucracy virtually unfettered power to make rules for which no need has been established - and then to set fees to pay for a level of enforcement that it alone decides.
* makes claims for the benefits of regulation that in fact can be achieved through simpler and less expensive means.
* proposes extending Australia's protectionist barriers to New Zealand, in direct contradiction to the supposed goal of freeing-up trade.
* is likely to eliminate hundreds or thousands of safe products from the New Zealand market without justification, thus limiting consumer choice.
COST-BENEFIT ANALYSIS
It is of extreme concern that the public has been required to comment on the Discussion Paper in the absence of an independent cost-benefit analysis. The New Zealand Institute for Economic Research has been commissioned to prepare such an analysis. Citizens for Health Choices is aware that many New Zealand firms and individuals contributed to the NZIER study more than six months ago.
Nonetheless, the study is yet to be released, and our request for access to the relevant material has been denied in terms of the Official Information Act. The Government and its officials have thus put us, and all submission-writers, in the position of assessing the proposal in the absence of a key piece of information.
PART II: CFHC'S VIEW ON THE DISCUSSION PAPER
In this Part of our submission, we respond to the Discussion Paper under the following headings:
* What is the "§problem" to be fixed?
* The need for a separate category for dietary supplements
* Risk management of dietary supplements
* Funding and fees of the Agency
* Objectives of the proposal
* Accountability of the proposed new Agency
* Recognition of international standards
* The proposed ¡§positive list¡¨
* Claims and advertising
* Appeals and enforcement
* Code of good regulatory practice
WHAT IS THE "PROBLEM" TO BE FIXED?
The Discussion Paper does not demonstrate that there is a problem with dietary supplements currently on the market in New Zealand.
Indeed, it states that around 95% of complementary healthcare products would fall into the low-risk category (p. 101). What is the justification for extensively regulating products that are known at the outset to cause almost no problems?
Medsafe has from time to time provided anecdotes of supposed harm from dietary supplements to support tighter regulation.
These anecdotes:
* are frequently based on unscientific assertions as to cause and effect
* typically relate to products that are illegal now ¡V and therefore make a case for enforcement of the existing rules, not for new rules
* where valid, demonstrate issues that can be resolved more simply and efficiently than through the proposals in the Discussion Paper.
Conversely, if regulation of the type proposed is worthwhile, after 10 years of similar regulation there should be evidence that Australian consumers of dietary supplements are any safer than their New Zealand counterparts. No such evidence is presented.
THE NEED FOR A SEPARATE CATEGORY FOR DIETARY SUPPLEEMTNS
The proposal takes for granted - without acknowledging nor analysing its assumptions - that dietary supplements should be treated as medicines. No consideration is given to treating them as a sub-category of foods (as in New Zealand) or in a separate category of their own.
To the best of our knowledge, Australia is the only industrialised country that insists on a strict medicines-food dichotomy in this way. Other countries acknowledge that dietary supplements are different both from medicines and foods - in purpose, usage, ingredients and risk profile - and thus regulate them in a separate category.
RISK MANAGEMENT OF DIETARY SUPPLEMENTS
The proposed regulations are supposedly based on a risk management approach (p. 98), yet the proposal fails to take proper account of relative risk.
It is obvious that a risk-based approach requires that a risk assessment be undertaken to determine actual risk. The Discussion Paper offers no such analysis, and thus does not attempt to justify putting dietary supplements under the same regime as medicines.
New Zealand's current regulations, which regulate dietary supplements as a category under the Food Act, are closer to the mark in terms of risk management.
It is a key point that most supplements are safer than many foods, and should be regulated accordingly.
It is not justifiable to place dietary supplements at the ¡§low risk¡¨ end of a continuum that includes the highest-risk pharmaceutical drugs. Those products do not belong in the same diagram, let alone in the same regulatory regime - except, presumably, that this is how it is done in Australia.
FUNDING AND FEES OF THE AGENCY
Among the Discussion Paper's fatal flaws is that the proposed Agency has no maximum budget, has no limits on its fee-setting ability, decides the extent of its own work programme, and the operating costs would be fully funded by fees and charges recovered from industry (p.20).
This gives the Agency unfettered power to levy taxes in order to meet a work programme that it alone decides, enforcing rules it alone sets. There is no other trans-Tasman police force with such powers.
There must be prior restraint on fee levels, and on the Agency's powers to set fees and enforce compliance. Since fee levels will be driven directly by the level of enforcement, the onus of proof must be on the Agency and its Directors to show that enforcement is proportionate to risk. Further, cost minimisation should be an explicit goal of the Agency, in order to restrain its otherwise unlimited powers to decide enforcement levels paid for by others.
It is completely unacceptable, for example, to adopt the Australian situation, where complementary healthcare products incur 25% of the therapeutic product fee income of the Australian Therapeutic Goods Agency, despite causing less than 1% of the risk.
In Australia, new ingredients's whatever their history of safe use, cost an average of $12,000 to register. Products cost several hundred dollars to register in the first year, and hundreds of dollars a year more to keep on the market. It is of real concern that the Discussion Paper provides no indication of the proposed fee levels - thus making it impossible for consumers and industry to estimate the effects of the proposals in the real world.
Given the very low levels of risk posed by dietary supplements, any significant fees higher than a few dollars per registration, are unjustified. Certainly the current proposal leaves the door open to significant abuse of bureaucratic power that cannot be justified by risk.
The method of paying for food regulation is instructive. The costs of the new food regulations coming into force in New Zealand in 2002 are to be paid out of general taxation. Given that the food industry causes more risk and more actual harm, there can be no justification for paying the cost of any regulation of dietary supplements through industry fees while food regulation is paid from general taxation.
Using general taxation to pay for any increased regulation of dietary supplements has another advantage, in that it provides an external and democratic check on the powers of the Agency. It must seek an Appropriation through the Parliaments of the two countries, thus ensuring ex ante scrutiny of its enforcement plans.
Finally, it is of concern that the current "low-volume" concessions available in Australia are not mentioned in the Discussion Paper. Significant fees would have the effect of driving low-volume products (and their manufacturers and distributors) off the market.
AS THE MINISTER OF HEALTH NOTED RECENTLY:
"It is certainly possible that distributors will choose to remove from the market some products with very low sales volumes." (Hon Annette King, letter to correspondent, 28 June 2002)
There are hundreds of these "low-volume" products, and they play a valuable role.
They are often:
* required by people with rare or unusual conditions, in order to meet their particular needs.
* are at the leading edge in terms of innovation, and thus promote competition and genuine choice.
Any fee settings that push low-volume products off the market would have the effect of "McDonalds-ising" the dietary supplements market to the detriment of consumers and their health. Innovation has been severely limited in Australia since the introduction of the TGA regime.
OBJECTIVES OF THE PROPOSAL
It can be seen from the above that the proposed regulations clearly do not meet the objectives set out in the Discussion Paper.
THE PROPOSAL STATES:
"The regulatory framework should be designed to manage the risks in a way that is efficient and cost-effective, does not impose inappropriate compliance costs on the industry, and does not unnecessarily restrict the range of dietary supplements consumers are able to access." (p. 90).
But the proposal contains regulations that are not justified by risk factors, and that will effectively restrict the range of dietary supplements by imposing inappropriate compliance costs -- such as licensing fees (p. 21), special labelling (p. 52), lengthy forms (pp. xii & 27), and appeals processes (pp. 132 & 138-142).
It is curious that another supposed objective of the proposal has been omitted from the Discussion Paper. In many discussions with the relevant Medsafe team, it has been stated that one of the purposes of the proposal is to lend "credibility" to the dietary supplements industry. Indeed, at an industry meeting hosted in Wellington by Medsafe in early May, Australian industry representatives said that this "and specifically not safety or risk management" was the chief benefit of the proposal.
Yet credibility is surely up to any industry to earn, and most sectors have Industry Associations specifically for that purpose. The notion that government should compulsorily tax a whole industry in order to enhance its reputation is an obnoxious hoax from the point of view of consumers - and raises the spectre of a supposed 'regulator' that is actually captured by industry interests.
There is no evidence that as a result of the Australian regime that Australian dietary supplements enjoy any more credibility than do New Zealand dietary supplements.
ACCOUNTABILITY OF THE PROPOSED AGENCY
The proposal creates an extremely powerful Managing Director and Board appointed by the Health Ministers of both countries to run the new Joint Agency (pp. 3 & 166).
The appointed executive would make decisions that are presently made by the Minister of Health, an elected official who is publicly accountable (p. 4).
The Agency will have unfettered power to make rules and orders (p.9), then enforce the rules and orders, (pp. 132-137) and determine the level of enforcement (p. 132) and set fee levels (p. 21).
Stakeholder input is very limited. There would be only two meetings a year to discuss issues of concern to the industry and consumers ¡V and those would be merely advisory. The people who make, import, sell and use dietary supplements will be effectively excluded from the decision-making process.
New Zealand sovereignty is not protected. Australians will dominate the Board. Three out of five members are to be Australian citizens, and all instruments of appointment to be signed by the Australian Minister on behalf of the MC [Ministerial Council] (p. 162). In cases of dispute over Board appointments, the Australian Health Minister will appoint two members, while New Zealand only appoints one (p. 3). It is unacceptable that, in any disagreement, the Australian minister would make most of the final decisions.
A number of CONSTITUTIONSL DILEMMAS also lead us to question whether there will be sufficient accountability on the Managing Director and Board:
* Will Australia really accept New Zealand¡¦s Official Information Act, which is considerably more liberal in terms of access to, for example, Cabinet papers? Or will New Zealanders have to accept poorer access to information on regulation of health products than they enjoy on other topics?
* Will Australia really accept the jurisdiction of the New Zealand Ombudsman?
* Will the Regulations Review Committee of the New Zealand Parliament have any real oversight? And with what authority or influence in Australia?
* Should New Zealanders have to accept binding rulings on their access to products being made by Australian courts? And will Australians really be bound by decisions made by the New Zealand courts, including the Privy Council (which otherwise has no jurisdiction in Australia) or by the proposed Supreme Court of New Zealand?
RECOGNITION OF INTERNATIONAL STANDARDS
It is a significant oversight that the Discussion Paper provides only superficial information on the regimes in countries other than Australia. There is no meaningful analysis of these, nor reasonable justification of why, out of all the other models available in the world, the Australian system is considered the appropriate starting point for regulation of dietary supplements.
If supplements are approved for safe use overseas in countries with high standards, they should be accepted for use in New Zealand. If supplements are acceptable in the USA, Canada, Britain and Europe, why would they harm New Zealanders? Many of these supplements have been used safely in New Zealand for 20 to 30 years.
A number of aspects of the Australian regime should not be imported into New Zealand. Each of these proposed country-specific rules will have the effect of taking off the market some of the highest-quality dietary supplements from around the world for no good reason:
* Any unique labelling requirements will impose unnecessary additional costs on dietary supplements imported from countries other than Australia. In Australia, all complementary medicines must include a TGA-approved claim on the label.This rule alone would force many safe dietary supplements off the New Zealand market, as it is too small to bear the extra costs (pp. 101-103).
* Any other special rules for dietary supplements in New Zealand and Australia would also create additional costs and would effectively ban some products - for example, requiring the product licence number on all labels. (It is instructive that the new labelling requirements for the New Zealand food industry, controlled under the Australia New Zealand Food Authority (ANZFA), have already cost food manufacturers millions of dollars and may force some imported and small-volume products off the market (See NZ Herald, 3 June 2002 - clipping attached). This may be justified for food, and seems to have been accepted by food manufacturers, but the effects on international trade and thus competition are acknowledged. The equivalent costs are not justified for the dietary supplements sector when the benefits proposed are available through other means.)
THE PROPOSED 'POSITIVE LIST'
We do not accept that the 'positive list' is an appropriate method for regulating the ingredients in dietary supplements.
'Positive list' systems are cumbersome and expensive, requiring both a safety review by the regulator and additional fees (currently in Australia a minimum of AU$10,000) before a new ingredient can be added to the list (p. 99). This lengthy and expensive process is not appropriate for dietary supplements.
New Zealand's 'negative list' bans certain substances from sale. This is efficient and cost-effective, and has not been shown to compromise the safety of consumers in New Zealand or the many other countries where negative lists operate.
The positive list system is sometimes seen as a way of eliminating supposed loopholes that enable suppliers to market as 'dietary supplements' dangerous and unknown products (e.g. "party drugs") that would not be allowed under any other category. We point out that such products are illegal now, since they are not covered by the current definition of dietary supplements in New Zealand (see Part III). There is no reason to believe that a supplier willing to flout the current negative list system would be any more constrained by self-certification under a positive list. Such issues are best dealt with through positive enforcement.
It is acknowledged that the Discussion Paper includes a proposal to expand the current Australian 'positive list' to include ingredients safely available in New Zealand (pp. 105 & 150). This does not address the new-ingredients issue discussed above. Further, the proposal to expand the positive list is acceptable only if this exercise "is funded as part of the Government-funded set-up costs of the Agency" as proposed on page 105.
PRODUCT CLAIMS AND ADVERTSISING
It is positive that the proposal would enable the use of approved claims (indications) for dietary supplements (pp. 101-103). Clearly the legislation in New Zealand needs to be changed - but this can be done without imposing a system of fees, licences and advertising controls.
It should be noted that given the number of dietary supplements on the New Zealand market (estimated at 20,000 to 25,000 products), the 'problem' of false claims is minute. There appears to be a lack of will to enforce current laws in New Zealand - presumably reflecting a rational judgement by the regulator that these products are safe compared to other enforcement priorities.
In product information or advertising, any truthful statement should be lawful. If someone tells an untruth, then the Fair Trading Act, Commerce Act and Advertising Standards Authority can and should be brought into force. Advertising controls must not be included in the jurisdiction of any proposed Joint Agency. Advertising controls do not belong under a Joint Agency scheme, nor should they be under the jurisdiction of the Ministry of Health in New Zealand.
Putting a claim on the label must be voluntary. If there are no claims being made, then at most, a simple notification to the Ministry of Health that the product is on the market, along with name of product, name of manufacturer, name of distributor, and basic ingredient information, would be sufficient. This simple notification system should include dietary supplements making low-level claims such as the structure and function claims allowed in the USA.
APPEALS AND ENFORCEMENT
As discussed above under fees, the Agency would have the power to conduct random audits, but no principles for, or limits on, such powers are specified (p. 106). The Executive would have the power to decide when, how, what and who is audited and whether fees or sanctions are imposed.
It is proposed that only "certain regulatory decisions would be subject to review" or "ppeal" (p 34). All regulatory decisions must be open to review.
Where appeals are allowed, no indication is given about length or cost of this process (p. 104). Suppliers will be opposed in court by a regulator that they fund, and who can pass its legal costs back to the industry. Effectively, suppliers will be dragged through the courts with their own money.
The "power to take prosecutions through the New Zealand and Australian courts to impose criminal sanctions" (p. 132) gives the Agency far too much power. This power should remain in the country of origin, and in New Zealand the Fair Trading Act and the Commerce Act cover this area adequately.
GOVERNMENTS CODE OF GOOD REGULATORY PRACTICE
It is apparent from the discussion above that the proposal does not meet New Zealand's Code of Good Regulatory Practice.
The Code requires regulations that:
* are the minimum required, and least distorting, in achieving the desired outcomes. The desired benefits can be achieved through much simpler means, and without distortions such as eliminating safe products through compliance costs and fees.
* have benefits that outweigh costs. This analysis cannot be done on the basis of the Discussion Paper, as benefits are not quantified and costs are unknown (but potentially limitless).
* have reasonable and fair compliance costs. See above.
* have a minimal negative impact on competition. This proposal is likely to eliminate hundreds of products, thereby reducing competition and innovation.
* are compatible with relevant international or internationally accepted standards or practices, in order to maximise the benefits of trade. This proposal uses very limited comparisons with other countries. No meaningful comparison with the USA system is included. Further, it would have the effect of restricting trade. New Zealand has few trade barriers in dietary supplements now; any compromise with Australia's rules would create international trade barriers where few now exist.
