Legislation affecting CAM products and practitioners

Chiropractors Act 1982

·        The purpose of this Act is to 'provide for the registration and discipline of chiropractors'.

·        The Act requires all chiropractors who intend to practise in New Zealand to register with the Chiropractic Board.  In order to register, chiropractors must hold approved qualifications and pay an annual fee.

·        The Chiropractors Act 1982 sets out the responsibilities of the Chiropractic Board in detail.  These include maintaining a register of chiropractors, encouraging high standards of professional education, and dealing with disciplinary matters.

Code of Health and Disability Consumers’ Rights          

·        The code confers a number of rights on all consumers of health and disability services in New Zealand.  It places corresponding obligations on providers of those services, including those who practise CAM.

·        The code covers all registered health professionals.  It also brings a level of accountability to all those who might be considered to lie outside the mainstream of medical practice (for example, naturopaths, homoeopaths and acupuncturists).

·        It is the duty and obligation of providers to comply with the code to ensure that they promote awareness of it to consumers, and to enable consumers to exercise their rights.

·         Under the code, the 10 rights of consumers and duties of providers are as follows:

Right 1:	The right to be treated with respect
Right 2:	The right to freedom from discrimination, coercion, harassment and exploitation
Right 3:	The right to dignity and independence
Right 4:	The right to services of an appropriate standard
Right 5:	The right to effective communication
Right 6:	The right to be fully informed
Right 7:	The right to make an informed choice and give informed consent
Right 8:	The right to support
Right 9:	Rights in respect of teaching or research
Right 10:	The right to complain

Consumer Guarantees Act 1993

·         The purpose of the Consumer Guarantees Act 1993 is to 'amend the law relating to:

(a)              The guarantees given, or deemed to be given, to consumers upon the supply of goods or services; and

(b)              The rights of redress against suppliers and manufacturers in respect of any failure of goods or services to comply with any such guarantees'.

 

·         The following sections of the Consumer Guarantees Act 1993 are particularly relevant to CAM products:

 

Section 6:	the guarantee as to acceptable quality (reference to safety)
Section 7:	the meaning of ‘acceptable quality’
Section 8:	guarantees as to fitness for a particular purpose
Section 9:	the guarantee that goods comply with their description.

Fair Trading Act 1986                                              

·         The main purposes of this Act are to prohibit certain conduct and practices in trade, to provide for the disclosure of consumer information relating to the supply of goods and services, and to promote product safety.

·         The following sections of the Fair Trading Act 1986 are pertinent to CAM practitioners and products:

Section 9:	misleading and deceptive conduct generally
Section 10:	misleading conduct in relation to goods
Section 11:	misleading conduct in relation to services
Section 13:	false representations.

   

Food Act 1981

·         The Food Act 1981 was enacted in order to ‘consolidate and amend the law relating to the sale of food’. The definition of food is such that it would include some CAM products. Food is defined in the Act as:

'anything that is used or represented for use as food or drink for human beings; and includes:

 

(a)              Any ingredient or nutrient or other constituent of any food or drink, whether that ingredient or nutrient or other constituent is consumed or represented for consumption by human beings by itself or when used in the preparation of or mixed with or added to any food or drink; and

• (b)              Anything that is or is intended to be mixed with or added to any food or drink; and

• (c)              Chewing gum, and any ingredient of chewing gum, and anything that is or is intended to be mixed with or added to chewing gum'.

 

·         The following sections of the Act are particularly relevant to CAM products:

 

Section 9:        general prohibition on sales  

Section 10:       misleading labelling and packaging

Section 11:       restrictions on advertising.

 

·         Regulations made under the Food Act 1981 include:

 Food Regulations 1984

The Food Regulations 1984 establish general labelling requirements for food, and general standards for vitamins and minerals. They also establish specific standards and labelling requirements for different food groups. These regulations also cover food additives, and the protection and safety of food.

Dietary Supplements Regulations 1985

These regulations were made pursuant to section 42 of the Food Act 1981. They establish general requirements, such as maximum daily doses and therapeutic claims. They also establish specific requirements regarding, for example, tableting aids and preservatives.

Many complementary and alternative health products are deemed to come under the definition of dietary supplements. The definition of dietary supplement given in these regulations is as follows:

‘any amino acids, edible substances, foodstuffs, herbs, minerals, synthetic nutrients, and vitamins sold singly or in mixtures in controlled dosage forms as cachets, capsules, liquids, lozenges, pastilles, powders, or tablets, which are intended to supplement the intake of those substances normally derived from food’.

 

Australia New Zealand Food Standards

A co-operative arrangement has been agreed between New Zealand and Australia to develop and implement uniform food standards. These standards will have the force of law, although they are currently still being phased in. The new joint Australia New Zealand Food Standards Code (joint Code) was implemented in December 2000. There is a two-year transitional period during which businesses can comply with either the joint Code or the Australian Food Standards Code (AFSC) in Australia, or the New Zealand Food Regulations 1984 (NZFR) in New Zealand. After the two-year transitional period the AFSC and the NZFR will be repealed, leaving the joint Code as a common set of food regulations in Australia and New Zealand.

The Food Standards Code is a collection of individual food standards.   Chapter 1 deals with standards that apply to all foods. However, New Zealand regulates its own maximum residue limits (MRLs) for food, so Standard 1.4.2 regulates MRLs in Australia only.   Chapter 2 deals with standards affecting particular classes of foods.   Chapter 3 deals with food hygiene issues in Australia.   New Zealand has its own food hygiene arrangements, and food hygiene is not part of the joint food standards system.

Health and Disability Commissioner Act 1994                 

·         This Act may impact on CAM practitioners.  The purpose of the Act is to:

'promote the rights of health and disability consumers, and, in particular,

 

(a)              To secure the fair, simple, speedy, and efficient resolution of complaints relating to infringements of those rights; and

(b)              To provide for the appointment of a Health and Disability Commissioner to investigate complaints against persons or bodies who provide health care or disability services; and to define the Commissioner’s functions and powers; and

(c)              To provide for the establishment of a Health and Disability Service Consumer Advocacy Service; and

(d)              To provide for the promulgation of a Code of Health and Disability Services Consumers’ Rights; and

(e)              To provide for matters incidental thereto'.

 

Medical Practitioners Act 1995                                                      

·         This Act is relevant to registered medical practitioners (ie doctors) who also practise CAM.  The purpose of the Act is to:

 

'consolidate and amend the law relating to medical practitioners, and in particular:

 

(a)              To impose various restrictions on the practice of medicine; and

(b)              To provide for the registration of medical practitioners, and the issue of annual practising certificates; and

(c)              To provide for the review of the competence of medical practitioners to practice medicine; and

(d)              To provide for the notification of any mental or physical condition affecting the fitness of a medical practitioner to practise medicine; and

(e)              To provide for the disciplining of medical practitioners; and

(f)                To provide for matters incidental thereto'.

·         Section 109 of the Act addresses grounds on which a medical practitioner can be disciplined. This section states that 'no person shall be found guilty of a disciplinary offence under this part of the Act merely because that person has adopted and practised any theory of medicine or healing, if in doing so the person has acted honestly and in good faith'.

 

Medicines Act 1981                                                  

·         The purpose of the Medicines Act 1981 is to 'consolidate and amend the law relating to the manufacture, sale, and supply of medicines, medical devices, and related products'.

·         The Act is broadly relevant to CAM products and practitioners. In the Act, the terms ‘medicine’ and ‘therapeutic purpose’ are defined. Part II discusses medicines and medical devices. Various sections state that manufacturers, wholesalers and packers of medicines are to be licensed. Part II also discusses the sale of medicines by retail. There are some exemptions that allow natural therapists to provide medicines to individuals, and in respect of herbal remedies administered to particular individuals. There is a section regarding quality and standards for medicines and medical devices. There is also a section on advertising.

·         The following sections are particularly pertinent to CAM:

    

Section 2:	interpretation (defines 'herbal remedy')
Section 3:	the meaning of 'medicine'
Section 4:	the meaning of 'therapeutic purpose'
Section 28:	exemptions in respect of herbal remedies
Section 32:	exemptions for natural therapists and others

 

• A 'herbal remedy' is defined in Section 2 of the Act as:

  'a medicine (not being or containing a prescription medicine, or a restricted medicine, or a pharmacy-only medicine) consisting of

   

  (a)              Any substance produced by subjecting a plant to drying, crushing, or any other similar process; or

  (b)              A mixture comprising two or more such substances only; or

  (c)              A mixture comprising one or more such substances with water or ethyl alcohol or any inert substance'.

   

  ·         A 'medicine' is defined in Section 3 of the Act as:

  'any substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally

   

  (a)              For administering to one or more human beings for a therapeutic purpose; or

  (b)              For use as an ingredient in the preparation of any substance or article that is to be administered to one or more human beings for a therapeutic purpose, where it is so used–

  (i) In a pharmacy or a hospital;

  (ii) By a practitioner;

  (iii) In the course of any business that consists of or includes the retail sale, or the supply in circumstances corresponding to retail sale, of herbal remedies;

  (c)        For use as a pregnancy test'.

   

  New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods     

  ·        This code has implications for the manufacture of CAM products.  It sets out standards for: 

  • the manufacture of pharmaceutical products

  • manufacture of blood and blood products

  •  compounding and dispensing generally, and specifically, compounding and dispensing of pharmaceutical products

  • wholesaling of medicines and medical devices

  • uniform recall procedure for medicines and medical devices.