Introduction
The Medicines Act and Regulations state what is, and is not, permitted when advertising medicines and medical devices. Devices that have, or are claimed to have, therapeutic properties must comply with the Medicines Act and Regulations.
Definition of advertising
Section 56 of the Medicines Act 1981 provides the key definitions relating to advertising of medical products. The definitions for advertisement and publish appear below. Advertisement means any words, whether written, printed, or spoken, and any pictorial representation or design, used or appearing to be used to promote the sale of medicines or medical devices or the use of any method of treatment; and includes any trade circular, any label, and any advertisement in a trade journal Publish means— Insert in any newspaper or other periodical publication printed or published in New Zealand; or Send to any person through the Post Office or otherwise; or Deliver to any person or leave upon premises in the occupation of any person; or Broadcast within the meaning of the Broadcasting Act 1976; or Bring to the notice of the public in New Zealand in any other manner Note that (e) covers the advertising of medical devices via the internet.
Legislation
The Medicines Act 1981 and its associated Regulations all place controls on the advertising of medical devices. These controls are broadly outlined below. Note that these controls are additional to any other legislative or regulatory controls on general advertising. Medicines Act 1981, Part 4 Medical Advertisements Part 4 comprises Sections 56 through 62 inclusive and references Schedule 1 of the Act. The sections of the Act are; s56 - Interpretation s57 - Restrictions on advertisements s58 - Further restrictions on advertisements s59 - Advertisements to contain true name of advertiser s60 - Exemption for certain advertisements s61 - Misleading branding s62 - Regulations relating to advertising Schedule 1 - Specific classes of diseases and physiological conditions Medicines Regulations 1984, Part 3 Advertisements Part 3 comprises Regulations 7 through 11 inclusive. The Regulations relevant to medical devices are; Reg. 7 - Advertisements not to claim official approval Reg. 10 - Advertisements for medical devices Reg. 11 - Advertisements for medical professions Medicines (Database of Medical Devices) Regulations 2003 Regulation 10 notes that a manufacturer or sponsor of a medical device may not claim that inclusion in the database is an endorsement of the safety or suitability for use of that product by the Director-General of Health or the Ministry of Health. Note that sponsors must ensure all of its advertising complies with all relevant legislation including the Fair Trading Act 1986 and the Commerce Act 1986 in addition to the Medicines Act 1981.
Claiming a therapeutic purpose
Claiming a therapeutic purpose for a product defines it as a therapeutic product and subject to the requirements of the Medicines Act 1981 and its Regulations. Understanding how the claim of a therapeutic purpose may impact on the regulation of a product will help prevent potential breaches of the legislation. A claim might be overtly made or implied. See also: Explanation of Therapeutic Claims
Pre-vetting services
The Association of New Zealand Advertisers provides a pre-vetting service for advertisers of therapeutic products. The Therapeutic Advertising Pre-vetting System (TAPS) will review advertising material (including websites) for compliance with the relevant codes and Regulations. Alternatively advertisers may wish to use consultants with experience in therapeutic product advertising to ensure compliance with the legislation and regulations.