Compliance with the Medicines Act 1981
Guidance for Natural Health Practitioners
Reviewed May 2012
This guidance document is prepared for individuals and businesses that are operating as natural health practitioners. The document outlines the specific exemptions granted under the Medicines Act 1981 only. Businesses must also comply with other applicable legislation such as the Fair Trading Act 1986 and Consumer's Guarantee Act 1993.
The Medicines Act 1981 ("the Act") sets out controls on the manufacture, supply and advertising (promotion) of medicines and also defines the term "medicine". Apart from a few limited circumstances that are set out in the Act, medicines cannot be advertised, sold or distributed unless they have first been approved by the Minister of Health. The approval process involves an application comprising information about the safety, efficacy and quality of the product, accompanied by an appropriate fee. This is followed by an evaluation of the information after which the Minister of Health may approve the product by notifying consent in the New Zealand Gazette.
Special provisions relating to Natural Therapists (Section 32 of the
Natural Therapists (and others) have specific exemptions from some of the requirements of the Act in recognition of their role. The effect of the exemption is to allow Natural Therapists to manufacture, pack, label, sell by retail, or supply certain medicines even when they have not been approved by the Minister of Health providing they are supplied to an individual following a consultation with the practitioner.
The unapproved medicines that can be supplied in this way are known as general sales medicines. A general sales medicine is one that does not contain an ingredient that is scheduled in the Misuse of Drugs Act 1975 (refer www.legislation.govt.nz), or one that has been classified under the Medicines Act as a prescription, restricted (pharmacist-only), or pharmacy-only (pharmacy) medicine. The classification of ingredients under this Act can be ascertained by using the Medsafe classification search at www.medsafe.govt.nz/profs/class/classintro.asp.
What is a "consultation"?
A consultation is not defined in the Medicines Act but interaction between any practitioner and a patient is covered by the Code of Health and Disability Services Consumers Rights 1996 made under the Health and Disability Commissioner Act 1994 (http://www.hdc.org.nz/theact/theact-thecode).
For the purposes of this guide a consultation should be a genuine dialogue between the Natural Therapist and the patient whereby the Therapist attempts to establish the patient's ailment and any additional circumstances that mean particular treatments should not be administered. This should include consideration of interaction with other treatments or pre-existing medical conditions.
Care must be given to treat the patient with respect and therefore the Therapist must ensure consideration is given to patient privacy and confidentiality. It is advisable that consultations are conducted in private.
What Natural Therapists can do when operating under the Section 32
People wishing to practise natural medicine may do the following within the context of providing care to a patient:
- Obtain any general sales medicine on behalf of a patient or for subsequent supply to a patient following a consultation with that patient;
- Prepare, blend or formulate a general sales medicine on behalf of a patient or for supply to a patient following a consultation with that patient;
- Label products supplied to the patient under the exemption with information regarding the intended therapeutic use, providing that the label meets the requirements of the Medicines Regulations 1984;
- Display information sheets pertaining to the therapeutic use of ingredients or blends of ingredients (but not products);
- Display any general sale medicine (providing it is not labelled with intended therapeutic uses) and add the label describing the therapeutic use of the product following a consultation;
- Advertise the services they provide as long as the advertisement does not breach restrictions in Section 58 of the Act that relate to advertisements for methods of treatment; and
- Provide specific information on a product to a patient providing that the information contained in it was discussed during a consultation with the patient.
What Natural Therapists can't do
The exemptions for Natural Therapists do not extend to being able to advertise unapproved general sales medicines. This means Natural Therapists cannot do the following:
- Display products that are labelled so as to state or imply a therapeutic purpose unless those products have been approved as medicines;
- Advertise or display product advertising that implies the product has a therapeutic purpose;
- Advertise methods of treatment to prevent, alleviate or cure the diseases or conditions listed in Part I of the First Schedule to the Act;
- Advertise methods of treatment to prevent or cure the diseases or conditions listed in Part II of the First Schedule to the Act;
- Supply medicines or products with ingredients that have been classified as prescription, or restricted (also referred to as pharmacist-only), or pharmacy-only medicines under the Act; and
- Supply unapproved medicines to the consumer without first being consulted by the consumer about the appropriate treatment for their condition.
Examples of the Exemptions in Practice
A Natural Therapist may have a retail store selling dietary supplements and cosmetics. A consumer may approach the therapist and seek treatment for any disease or ailment. During the consultation the therapist may recommend any product, group of products to work synergistically, or individual ingredients.
Following the consultation the therapist may select products from the retail shelves and attach a label indicating the therapeutic use of the product. Labels must comply with the requirements of the Medicines Regulations 1984.
A Natural Therapist may have a consultation room and display products in the waiting room. The products on display may, for example, be herbal remedies or homoeopathic preparations but cannot be labelled with the therapeutic use of the product. Also on display may be educational material on ingredients or therapeutic practises but this material cannot indicate or imply that any products or any products on display are for a therapeutic purpose.
Following the consultation, remedies may be selected and labelled for use. Additional, product-specific information may also be provided to assist the patient with their recovery.
A Therapist may advertise his/her services to the public. For example, a herbalist could advertise that he/she is a herbalist and could offer treatment services and then list the kinds of conditions the services might cover.
However, a Therapist cannot advertise that they specialise in treating a specific condition using a named product.