Natural Health Products Bill

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Explanatory note

General policy statement

The Natural Health Products Bill establishes a system for the regulation of low-risk natural health products in New Zealand.

Natural health products include herbal remedies, traditional treatments, homeopathic remedies, and dietary supplements. The system will, for the first time in New Zealand, introduce risk-based regulation of natural health products. It will use an approach that enables product sponsors to gain market authorisation by self-certification against the system requirements.

The Bill provides for—

  • the establishment of a natural health products regulator within the Ministry of Health:

  • natural health products to be notified to an online register:

  • recognition of assessments by approved regulators of ingredients, claims and evidence of health benefits, and manufacturing standards:

  • a list of prohibited ingredients:

  • notification of new ingredients prior to marketing:

  • export certification:

  • an appeals mechanism:

  • regulation-making powers to set labelling requirements, manufacturing standards, and standards of evidence required to make a claim of health benefit:

  • an exemption from notification and manufacturing requirements for certain categories of product, including those made by a practitioner for a patient:

  • the appointment of a technical expert advisory committee.

Regulatory impact statement

The Ministry of Health produced a regulatory impact statement in December 2010 to help inform the main policy decisions taken by the Government relating to the contents of this Bill.

A copy of this regulatory impact statement can be found at—

Clause by clause analysis

Clause 1 is the title clause.

Clause 2 provides for commencement of the Act to occur on a date fixed by the Governor-General by Order in Council. One or more orders may be made bringing different provisions of the Act into force at different times. This will allow time for the development of the natural health product database and for regulations that give effect to some parts of the Act to be made.

Part 1
Preliminary matters

Preliminary provisions

Clause 3 states that the purpose of the Act is to establish a system for the regulation of natural health products in New Zealand.

Clause 4 states the principles on which the Act is based.

Clause 5 provides for the interpretation of terms used in the Act.

Clause 6 defines natural health product. The key aspects of the definition relate to what the product contains, how it is to be administered, and the intended health benefit of the product.

Clause 7 provides that the Act binds the Crown.

Natural Health Products Regulatory Authority

Clause 8 establishes the Natural Health Products Regulatory Authority (the Authority), who is to be the Director-General of Health.

Clause 9 allows for the recognition of other regulatory authorities, whether in New Zealand or in any other country.

Natural health products advisory committee

Clause 10 requires the Authority to establish an advisory committee to provide expert advice to the Authority. The maximum number of committee members is 8. Each member must have expertise in an area of knowledge that relates to or is relevant to natural health products.

Natural health product database

Clause 11 requires the Authority to establish and maintain a natural health product database.

Sponsor

Clause 12 requires that the sponsor of a natural health product must be resident in New Zealand.

Part 2
Regulation of natural health products

Product notification of natural health products

Clause 13 requires the sponsor of any natural health product to be distributed in New Zealand to complete a product notification for the product. Product notification is to be made to the Authority and requires the sponsor to provide information about the product, the sponsor, the manufacturer, the health benefit claims made for the product, and any other prescribed information. Product notification is not required in respect of certain natural health products made by a practitioner for the treatment of a patient, any export-only natural health products, or any exempted natural health products.

Clause 14 allows the Authority to exempt, by notice in the Gazette, a natural health product or category of natural health product from the requirement to have a product notification.

Clause 15 allows the Authority to audit any product notification or class of product notification.

Clause 16 requires the Authority to suspend the product notification of any natural health product that the Authority has reasonable grounds to believe has caused, is causing, or is likely to cause harm to any person. The Authority may suspend a product notification if—

  • it has reasonable grounds to believe that the sponsor has given false, misleading, or incomplete information in the product notification; or

  • it has reasonable grounds for concern because of new information about the safety, quality, health benefit claims, or manufacturing standards of the natural health product.

The Authority may cancel the product notification if satisfied that the events leading to the suspension have occurred or that any concern leading to the suspension is justified. The effect of any suspension or cancellation is that the sponsor must stop distributing the product.

Clause 17 requires the sponsor of a notified natural health product to notify the Authority as soon as the sponsor becomes aware of any serious adverse reaction to the product.

Clause 18 sets out the situations when a new product notification is required for a natural health product.

Clause 19 enables the sponsor of a natural health product to cancel the product notification of the product if the product is no longer sold or supplied.

Ingredients of natural health products

Clause 20 empowers the Authority to declare any substance that belongs to any class of substance in the Schedule to be a natural health product ingredient. Clause 20(3) allows the Authority to conduct a safety assessment of the substance and sets out the criteria that the Authority must consider in its decision.

Clause 21 empowers the Authority to declare a substance to be a prohibited natural health product ingredient and sets out the criteria to be applied.

Every declaration of a natural health product ingredient or prohibited ingredient must be published on an Internet site maintained by or on behalf of the Authority. After making a declaration, the Authority must—

  • arrange for publication in the Gazette of a notice indicating that the declaration has been made; and

  • list the natural health product ingredient or prohibited ingredient on the natural health product database.

New ingredients

Clause 22 regulates the use of new ingredients in a natural health product. A new ingredient means any substance that belongs to a class of substance listed in the Schedule and that is not—

  • a natural health product ingredient; or

  • a prohibited ingredient.

Clause 23 provides for safety assessments of new ingredients.

Labelling

Clause 24 requires natural health products that are distributed in New Zealand to comply with the labelling requirements prescribed in regulations.

Exports

Clause 25 allows the sponsor of a natural health product to apply to the Authority for an export certificate. If the natural health product is manufactured in New Zealand but is not to be distributed in New Zealand, the sponsor must also hold a licence to manufacture.

Clause 26 provides that if a natural health product is also an animal product within the meaning of the Animal Products Act 1999, any application for an export certificate or a similar statement for that product must be made according to that Act instead of this Act.

Code of practice for manufacture of natural health products

Clause 27 requires the Authority to establish a code of practice for the manufacture of natural health products (the code).

Manufacture of natural health products

Clauses 28 to 34 relate to the manufacture of natural health products. A person, other than an exempted person, must not manufacture a natural health product without a licence to manufacture granted by the Authority.

The Authority may grant a licence to manufacture if satisfied that—

  • the applicant's manufacturing facilities meet the requirements of the code; and

  • the applicant is a fit and proper person to hold the licence.

It is a condition of a licence to manufacture that the licence holder must at all times comply with the code, and the Authority may, at any time, audit manufacturing facilities for compliance with the code or any condition imposed by the Authority.

Fees

Clause 35 authorises the Authority to prescribe, by notice in the Gazette, fees payable under this Act.

Sanctions and penalties

Clauses 36 to 40 prescribe offences in respect of the following:

  • deceptive conduct:

  • sale of natural health products that have not been notified or do not meet required standards:

  • manufacturing a natural health product without a licence:

  • obstruction of authorised persons:

  • endangerment of human health.

Disputes

Clause 41 establishes the Natural Health Product Appeals Committee to determine appeals made to it against decisions of the Authority.

Clause 42 relates to the making of appeals and allows a further appeal on a question of law to be made to the High Court.

Other powers of Authority

Clause 43 enables the Authority to publish statements relating to natural health products.

Clause 44 provides for the recall of natural health products.

Clause 45 enables delegations to be made by the Authority of its powers, functions, or duties under this Act.

Transitional provisions

Clause 46 provides transitional arrangements for products that were sold before the commencement of this Act and that—

  • comply with paragraphs (a), (c), and (d) of the definition of natural health product in clause 6(1); and

  • do not contain (as ingredients) any substance that does not belong to a class of substance listed in the Schedule.

Regulations

Clause 47 empowers the making of regulations on the recommendation of the Minister of Health after complying with certain consultation requirements.

Review of Act

Clause 48 requires the Ministry of Health to conduct a review of the policy of the Act no later than 5 years after the commencement of the Act.

Amendments to enactments

Clauses 49 to 56 make consequential amendments to the Medicines Act 1981 and to the Misuse of Drugs Amendment Act 2005.

Revocation

Clause 57 revokes the Dietary Supplements Regulations 1985.