From Amy Adams, Senior Lawyer - Simon Mortlock Partners.
Legal Advisor and spokes person for the New Zealand Health Trust, www.nzhealthtrust.co.nz, the organization in the front lines of the battle:
Recent work carried out by NZHT
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 could be classed as drugs and regulated by a joint agency modelled after the Australian Therapeutic Goods Administration.
NZHT has been leading the opposition to the joint agency since 2002 presenting evidence to Parliament of how damaging this proposal would be to the natural health options of New Zealanders. NZHT has shown that natural health products can be properly regulated in New Zealand by developing an alternative model of regulation centered around a system of good manufacturing practice (GMP) including controlled claims rules and a web site that will act as a product information center and point of self-regulation.
The NZ Health Trust asked the ANH for its opinion on this issue, and our view is being passed on to the Prime Minister of New Zealand, Helen Clarke.
As an international, European-based, alliance of natural health interests, including consumers, medical doctors, other health practitioners, lawyers, scientists and companies, the Alliance for Natural Health has been deeply engaged in assessing the impact of different regulatory regimes for natural health products in different parts of the world.
In relation to the development of regulatory models affecting natural health, and their relationship to New Zealand’s interest in developing its own regime, four general points can be made:
1. Increasingly stringent regulatory regimes are rarely, if ever, developed because of conclusive evidence of risk from use of natural health products which is then shown could be ameliorated through the implementation of the new regulatory model. Presently there is evidence that food constitutes a health risk to the New Zealand population that is intermediate between natural health products, which have by far the lowest risk of any ingested product, and licensed pharmaceutical products.
2. Pharmaceutical-based regulatory models impose requirements which are incompatible with many truly natural products that are comprised either of many different primary or active molecular forms or are complex mixtures of compounds that are naturally-occurring.
3. Such models therefore act in a disproportionate manner by both excluding some of the fully natural products, as well as providing a relatively greater regulatory burden for smaller companies. They will favour large trans-national corporations over local, New Zealand businesses, and they will lead to a lack of diversity and innovation in the marketplace – for which the New Zealand natural products market is renowned.
4. The European Union has seen fit to develop a regulatory regime for ‘food supplements’ which continues to view “concentrated sources of nutrients” as foods, rather than as medicines. Given that the EU model is essentially forming the template for international Codex Alimentarius guidelines for food supplements, the development of a pharmaceutical model for natural health products in New Zealand would be out-of-step with Codex, which is already considered by some to be overly restrictive. Additionally, the USA, which is home to one of the richest and largest markets for natural health supplements worldwide, continues to operate a food-based regime for ‘dietary supplements’.
In terms of the proposed Therapeutic Products and Medicines Bill, we have the following five additional comments:
1. There is no question that regulatory development of the natural products market in New Zealand could be initiated in such a way that it both ensures that public health risks are minimised, while, at the same time, it facilitates the expansion of New Zealand’s position as an international supplier of natural products. However, this would require that the existing plans of the Australia New Zealand Therapeutic Products Authority (ANZTPA) are disbanded and that the Therapeutic Products and Medicines Bill is rejected in its present form. The Bill, in our view, should be limited to conventional pharmaceutical products and medical devices.
2. If the New Zealand government is to embrace preventative health strategies, which would in turn greatly benefit its population and reduce the burden on its health service, all effort should be made to ensure that unnecessary, disproportionate regulatory burdens are not applied to natural health products so that the cost of finished goods can be minimised, so making them accessible to as wide a sector of the population as possible.
3. By embracing a disproportionate, pharmaceutically-based legislative system for natural health products on the basis of insufficient evidence, the New Zealand government may open itself to potential legal action by New Zealand businesses that are damaged by the new law.
4. The New Zealand government should recognize that there are many differences between the Australian natural products market, and that of New Zealand. The New Zealand market has for many years fostered a much greater diversity of natural product suppliers than the Australian market, and at the same time the New Zealand market would be much more negatively impacted by the development of a pharmaceutically-based regulatory model owing to the broad range of naturally-sourced, locally-produced products in the New Zealand marketplace.
5. New Zealand has the ability to lead the world with a regulatory model that is adapted specifically to the requirements of natural health products. Such a model would then provide an important precedent for other countries that are contemplating development of their own regulatory systems. By ensuring that the model is constrained by food rather than medicinal law, it will also be in keeping with the requirements of Codex Alimentarius, which is in the process of developing risk assessment methods specific to nutrients.
We sincerely hope that the New Zealand government will heed the views of the many experts in the New Zealand natural products industry, as well as others from outside, who have provided consistent warnings over the danger of harmonizing New Zealand’s laws on natural products with those of Australia.
Judging by the level of concern among New Zealand consumers, about which we have been aware for some time, it goes without saying that Trans-Tasman harmonization of natural products laws would be likely to be a deeply unpopular political move.
We would be very happy to help assemble an international expert panel as a means of providing advice to the New Zealand government on a new regulatory approach, which would seek to enhance the development of a competitive, robust, New Zealand natural products industry, both nationally and internationally. Such an approach would also ensure that consumers were properly informed and their health adequately protected, while ensuring that their freedom of choice was not unnecessarily limited.
on behalf of the Alliance for Natural Health
Robert Verkerk BSc MSc DIC PhD
Executive & Scientific Director
Alliance for Natural Health
Updated: 22 Jan 2008
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