New Bill for Natural Health Products in New Zealand
Tuesday 8th November 2011
The Natural Health Products Bill received support from both sides of the House after its first reading in Parliament recently. The Bill is also widely supported by the natural products industry in New Zealand.
The current regime is generally considered to be out of date and confusing due to its piecemeal structure – products for ingestion are covered by the Dietary Supplements Regulations 1985, while other natural health products are covered by the Medicines Act 1981.
The Natural Health Products Bill covers any product that contains only natural health product ingredients and is intended (by the manufacturer or importer) to be administered to a human being to bring about a health benefit.
A natural health product will not include food, medicines or controlled drugs, products to be administered by injection or application to the eye or ear, or products for the treatment of serious illnesses, ie. where self-diagnosis or self-management are not considered acceptable.
The purpose of the Bill is to ensure that natural health products are safe and provide the health benefits they claim. To achieve this, the Bill establishes an authority that will:
- maintain a database of allowable and unallowable ingredients;
- prescribe labelling requirements;
- require notification (registration) for all natural health products sold in NZ;
- prescribe manufacturing standards;
- require the recall of a product;
- require manufacturers to obtain a licence to manufacture; and
- conduct safety assessments on propose new ingredients.
Additionally, the Authority will provide New Zealand manufacturers that export goods with an export certificate for their products if they obtain a licence to manufacture and file a product notification. This will aid exporters in complying with requirements in other countries, although it will not be compulsory for exporters not supplying the New Zealand market to have a manufacturing licence or to file product notifications.
While generally seen as a positive step for consumer protection and the natural products industry in New Zealand, there will of course be compliance costs and liabilities:
- there will be application fees and annual fees for product notifications and manufacturing licences will have to be renewed every three years;
- for manufacturing without a licence or selling a product without a notification, there will be a fine of up to $250,000 for a body corporate and up to $50,000 for an individual; and
- for obtaining a notification by deception or knowingly endangering the health of the public, there will be a fine of up to $500,000 for a body corporate and up to $100,000 and five years imprisonment for an individual.
The Bill will go before the Health Select Committee next term and may be in force next year.
This article was written by Claire McInnes. Claire is a patent attorney based in our Wellington office.