“There will be no Aussie rules” article by Annette King

1. We have reviewed the Dominion Post article written by Minister King entitled
   “There will be no Aussie rules” and there are a number of comments in that
   article that must be addressed.
   
2. Firstly it must be borne in mind that the Minister and her Government have invested a huge amount of political capital in this legislation, having already irrevocably committed themselves and New Zealand to the Treaty with Australia without first seeking the support of the House. They now find themselves backed into a corner and not surprisingly are engaged in a full scale public relations campaign. Any assertion by Minister King of “fact” must be understood in this light. In this article the Minister makes assertions that not only would we dispute as being “fact” but that misrepresent the full reality of the proposed agency.
3. There are 9 key allegations made by the Minister that need to be addressed which we have done in bullet point form in the table below for ease of reading. More detail can be provided on any of these matters if requested.

Minister’s allegation	Response
It is not an Australian takeover	The agency will be, at law, an Australian corporation. The proposal amounts to a full adoption in NZ of the existing Australian style of regulation. While the Ministerial council is, and always has been, 50/50, this body will have little involvement in the decisions that will determine what products are permitted. Those decisions will be made by the Australian based managing director. NZ only has one appointee out of 5 on the agency board.
The Australian industry is thriving	The Minister does not detail which “industry” she is providing figures for nor provide any basis for the figures. There is nothing to suggest these numbers relate solely to the natural health industry which is the one under discussion The assertions made by the Minister as well as being unsubstantiated and undefined are completely at odds with the evidence presented to select committee from highly regarded participants in the Australian natural products industry. Val Johansson of Australia provided detailed evidence to the Government Administration committee on the extent to which the TGA style of regulation has in fact “crippled” the natural health industry in Australia

The proposed model does not involve a pharmaceutical based evaluation system. It is risk appropriate.	To claim that the proposed model is risk appropriate is a subjective assertion whic>h is disputed by industry The Government has never carried out an independent risk analysis on which it could base its claim that this model is risk appropriate. There are only two categories of product under the proposed agency. Class I products and Class II products. While class I regulation may lighter than class II regulation, neither are light regulation and even Class I is significantly more onerous than is demonstrably necessary. Not all natural products will even qualify for Class I regulation meaning they would be regulated alongside the most dangerous pharmaceuticals. The licensing costs that would be subsidised are only a small percentage of the total costs to business. The greater cost lies in the testing costs and high level GMP which apply to both class I and class II equally and which is unsubsidised
Rongoa Maori will not be regulated by the agency	The Minister continues to seriously misrepresent the true position. Rongoa Maori or any traditional health product manufactured for sale or commercialised in any way will be at the discretion of and under the control of the proposed agency The only known exemption to the agencies total control relates to formulations a practitioner makes up for an individual patient and this applies generally, not just to rongoa.
Natural Products NZ represents 80% of the industry	Natural Products NZ relies on proportional voting such that its biggest members, that are in the main Australian owned, determine the official position of the group. Its official position does not represent the views of the majority of NZ businesses in the natural health sector. Comvita, one of the largest NZ natural health businesses, opposes the proposed agency as do the overwhelming majority of small and medium sized businesses in the sector. Large businesses stand to profit from the model which is disproportionately onerous for small businesses. SME’s make up an estimated two thirds of the NZ natural products sector.
Natural health products have been responsible for at least 3 deaths in NZ	This often repeated allegation has not been properly substantiated and remains unproven. To the contrary, reports indicate that natural products in fact have a lower risk profile and are safer than everyday food. The Government itself accepts in the explanatory note to the Bill that NZ with its present light system of regulation has as good a record of public safety from natural products as Australia.
Natural products have been found containing everything from Viagra to arsenic	Once again this allegation has never been substantiated. If indeed such products have been found by officials then there should be details of the prosecutions that would have followed as such products would already be illegal under the NZ system. Any sensible system of regulation would make such products illegal. This in and of itself provides no justification for the decision to adopt the ANZTPA model in place of other options.
The scheme will not take away consumer choice or make dietary supplements illegal	This is an incredible statement for the Minister to have made given that she accepts there are over 700 ingredients used in NZ which are currently illegal in Australia. Any dietary supplement not on the approved list will, by definition, be illegal. Furthermore many businesses have given evidence that legal or not, their products will be removed from sale if ANZTPA proceeds because they will no longer be economically viable. It is indisputable then that consumer choice will be detrimentally affected. If a natural product is not approved by the agency then it becomes an illicit drug and the enforcement mechanisms planned and currently used in Australia are more in keeping with the prevention of terrorist activities than the importing of natural products. This includes reported instances of armed assault squads breaking down doors of private residences searching for natural remedies legally sold in other jurisdictions but not approved by the TGA.
“Snake Oil has had its day.”	The Minister’s references to snake oil demonstrate her prejudice towards a substantial and reputable industry producing products relied on by over 2.5 million New Zealanders These comments also show that the Minister has failed to grasp the basic premise of this debate. This is not about the need to regulate natural products to ensure proper standards of consumer protection and honesty of claims. That is accepted. The debate centres on what system of regulation is in New Zealand’s best interest. The fact that the Minister still thinks ANZTPA is required to prevent “snake oil” demonstrates that she has never opened her mind to any of the other regulatory options.