Health conscious New Zealanders are facing a threat to their freedom to choose natural ways and means for taking care of their health. According to an agreement between the governments of New Zealand and Australia, signed in December 2003, Natural Health Products are to be regulated by a joint agency modelled after the Australian Therapeutic Goods Administration. That agency has shown an extremely heavy-handed approach to supplements when last year in April, it pulled well over a thousand natural products off the market, on the strength of one manufacturer's lax handling of quality control standards.
New Zealand's newly organized resistance is centered around a web site that will act as a product information center and point of self-regulation, as well as a rallying point for the expected political battles around this issue. The site is not fully operational yet, but a newsletter is already being offered. Find out how to keep current on this issue. Thanks to David Holden and Liston Bateson for the information.
24 February 2004
To all those involved with Dietary Supplements or Natural Health
Contact: Amy Adams / Dave Sloan
E-mail: [email protected]
You may be aware that the Government is trying to change the way in which all Natural Health Products (NHPs) are regulated. They plan to treat NHPs as medicines and give the power to control them to the controversial Australian Therapeutic Goods Administration (TGA).
What is known from the Australian experience is that to treat NHPs as drugs and to make them subject to the heavy handed bureaucracy that goes with it will mean that many New Zealand businesses will be forced to close taking current products off our shelves. The products that do survive are likely to be much more expensive as suppliers are forced to recover regulation costs. What’s more, because regulation will come from Australia, there will be very little New Zealand can do to protect itself.
Despite strong opposition from industry and a Parliamentary Select Committee report against the proposal, Annette King signed the Treaty with Australia on 10 December last year. BUT the battle is far from over. The Government still needs to have the treaty passed into law and for that it needs support from other parties. ALL opposition parties in Parliament (National, ACT, Greens, United Future and NZ First) have now unanimously condemned the Governments actions.
This proposal will seriously limit our freedom of choice in New Zealand and our access to NHPs. To make sure it does not happen the industry needs to show organisation and a willingness to work within a sensible NZ system of regulation.
To do this the NZ Health Trust, which has been one of the leading objectors to the Government’s proposal, has developed a web site called myHealth to act as a national directory of NHP’s.
This site allows consumers to find out what products are available and how & where to get those products. It is a little like a web based ‘Yellow pages’ for NHP’s. Plus, by establishing the site we can show the Government the advantages of centralised web based, self registration systems rather than the heavy handed Australian approach. The site is in the final development stages for product listing and searches. The newsletter database function is complete.
We can stop the Government’s TGA proposal but only if we are strong & united.
Please log on to www.myHealth.co.nz and enter your name and email address in the newsletter section to subscribe to the myHealth newsletter and we’ll make sure you are kept informed. You can unsubscribe at any time and your details will only be used to send you items of specific information.
NEW ZEALAND HEALTH TRUST
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February 2004: Here are some first details on how the planned joint agency is to regulate supplements in both countries. Apparently, there will be a list of "allowed" substances similar to what the European food supplements directive has established, and what already exists under the present Australian system which classifies supplements as "therapeutic goods" under medicines law:
Medsafe has issued a request for sponsors to list products that have been supplied into the New Zealand market during the 2003 year. This is in order to compile a list of permitted ingredients for the Joint Agency. The Agency needs to have a permitted ingredients list for the joint agency prior to commencement of the joint scheme. Australia already has such a list under its current regulatory system, and the substances on that list will be transferred to the new joint agency's permitted ingredients list. Ingredients in complementary medicines marketed in New Zealand may also be able to be included in the list following an evaluation of safety and quality. Products containing an ingredient that is not on the permitted ingredients list will be permitted to be sold in New Zealand for the duration of a transition period provided that sponsors comply with the transition arrangements. During this time the sponsor will need to submit to the agency product licence applications for evaluation of each product the sponsor wishes to continue marketing.
It is to the sponsor's advantage to ensure that all ingredients are identified early so that evaluations can be completed and ingredients considered suitable included in the agency's permitted ingredients list. Sponsors are requested to compile a list of all ingredients included in products you are currently manufacturing or distributing in New Zealand, and declare that these ingredients are present in products that have been manufactured, imported or sold in New Zealand during 2003. Industry associations have agreed to collate lists from their members and forward a consolidated list to Medsafe.
In order for a 'master' list of ingredients to be compiled and for evaluation work to begin as soon as possible, Medsafe requires information by 31 April 2004.
March 2004: Information from MyHealth. You can subscribe to a newsletter directly on their site.
Many of you will be aware of the Government plans to set up a Trans Tasman regulator which will control this industry and which will be an effective extension of the Australian Therapeutic Goods Administration system. This proposal has been strongly criticised by those in the industry and was unanimously rejected by the Health Select Committee in its report in December last year.
The Government though is still trying to force the changes through that experts predict will result in the loss of many products currently available in New Zealand.
A report commissioned by the NZ Health Trust to analyse the Treaty signed with the Australians shows, among many other things:
1. The definition of therapeutic products is so wide that it would include anything taken for health reasons and for that reason arguably would cover fish, vegetables, water and potentially even oxygen.
2. Five stages of regulation are proposed; on importers of ingredients, manufacturers, suppliers, retailers and on exporters.
3. Whilst the Treaty claims to allow some differences in regulation between NZ and Australia, the criteria needed to permit those differences are so limiting that in reality differences would be highly unlikely to ever occur (except for traditional Maori remedies).
4. The Managing Director would have the full power to make rules controlling the industry and yet is not a public servant and does not have report to the Board.
5. Furthermore the powers of the Managing Director could be delegated and sub-delegated and could be carried out by someone of whom NZ has not approved.
6. The treaty enables the new body to further join up with some other international body leading to NZ having even less control than it would initially.
7. All advertisements of any sort, including printed matter supplied with products are to be subject to pre-vetting
8. Most of the detail as to the extent of the regulation has still not been made available meaning that the details of the costs to businesses are still unknown. Asking Parliament to authorise this new body without knowing these details is like asking someone to sign a contract they have not read.
If you want to read the Treaty and accompanying Fact Sheets for yourself these are available at www.jtaproject.com. The Government's response to the Select Committee report is also now available from the Ministry of Health.
Posted at February 24, 2004 12:03 PM
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