Pharmaceutical Advertising 2024 Comparisons

The advertisement and promotion of therapeutic products is governed by the Medicines Act 1981 (the “Medicines Act”) and the Medicines Regulations 1984 (the “Medicines Regulations”). Compliance with the Act and its regulations is monitored and enforced by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). 

There are also industry codes of practice that set out minimum industry standards for the ethical and responsible promotion of therapeutic products. These are: 

• the Medicines New Zealand Incorporation (MNZ) Code of Practice for the advertisement and promotion of prescription medicines (the “MNZ Code”); and 
• the Medical Technology Association of New Zealand (MTANZ) Code of Practice for the advertisement and promotion of medical devices (the “MTANZ Code”). 

These Codes of Practice are generally consistent with the legal requirements under the Medicines Act and its regulations. 

While compliance with industry codes is entirely voluntary, adherence is a condition of membership of those industry bodies.

Pharmaceutical and medical device companies must also comply with general consumer protection laws, including the Fair Trading Act 1986, which prohibits misleading and deceptive conduct “in trade”, and requires all therapeutic claims and representations to be substantiated. 

Pharmaceutical companies that are members of MNZ must comply with the advertising and promotion rules set out in the MNZ Code when advertising prescription medicines to consumers and healthcare professionals (HCP). 

While the MNZ Code does not have any direct legal effect, it is common for the terms of a subsidy listing agreement between New Zealand’s Pharmaceutical Management Agency (“Pharmac”) and a pharmaceutical supplier to require the supplier to comply with the relevant industry code for direct-to-consumer advertising for so long as the listing agreement is in place, irrespective of whether the supplier is a member of the industry body. 

Most pharmaceutical suppliers also comply with the advertising codes published by the Advertising Standards Authority (ASA). The ASA’s Therapeutic and Health Advertising Code (the “ASA Code”) applies to all direct-to-consumer and direct-to-HCP medical advertisements, and mostly reflects the minimum legal requirements under the Medicines Act and its regulations. 

While compliance with the ASA Code is voluntary, the compliance rate is generally high due to the significant publicity, including the attention of Medsafe and other regulators, an ASA breach decision usually attracts.

The Medicines Act defines “advertisement” as “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”.

A “medical advertisement” is an advertisement that relates, or is likely to cause any person to believe that it relates, to any medicine or medical device. 

This definition captures all online and traditional forms of promotional activities and communications, whether directed at consumers or HCPs (or both), as long as the activity or communication: 

• “relates or is likely to cause a person to believe that it relates” to a medicine; and 
• has as its primary purpose to “promote the sale” of the therapeutic product. 

This commercial driver that forms the basis of what constitutes a medical advertisement was removed under the Therapeutic Products Act 2023, which was enacted on 26 July 2023 to replace the current Medicines Act and its regulations. 

This change was strongly opposed by a number of interested parties, including MNZ. MNZ submitted that the broadening of the term “advertisement” to capture all forms of communications that “promote” a therapeutic product, regardless of the purpose of that promotion, would have a number of unintended consequences. For example, “Give-a-Little” pages created by patients and their families to raise donations to help privately fund medicines for the patients’ treatment would potentially be captured. 

The Therapeutic Products Act (which was to come into force in 2026) will now be repealed under the new coalition government formed in November 2023. Therefore, the Medicines Act and its regulations are still the relevant laws that currently apply to the advertising and promotion of medicines in New Zealand.

The key distinction between patient information-sharing or a disease awareness campaign from a medical advertisement is the primary purpose for which the activity or communication is undertaken. 

The statutory definition of “medical advertisement” requires that the promotion of the sale of medicines must be the primary purpose of the activity or communication to constitute a “medical advertisement”. 

The statutory definition of “medical advertisement” is replicated in the MNZ Code and it goes further to also distinguish that concept from a “disease awareness” activity or communication, which is not a concept in the Medicines Act. The MNZ Code defines “disease awareness” as follows: “Disease awareness activities provide information, promote awareness and educate the public about health, disease and their management. The emphasis must be on the condition and its recognition rather than treatment options (eg, cover key characteristics of the disease). Such activities must not reference a specific medicine. The awareness activity may make reference to the availability of different treatment options, however, it may not be designed to encourage a patient to request the prescription of a specific medicine.”

It is therefore the presence (or absence) of the commercial driver behind the promotion that distinguishes an activity or communication from being a “medical advertisement” as opposed to a “disease awareness” campaign or general information-sharing directed to patients in the form of patient leaflets, patient support programme pamphlets, etc.

For example, if the disease awareness campaign or patient-facing information only refers to treatment options, no “specific medicine” is mentioned (expressly or impliedly), and it is “not designed to encourage a patient to request the prescription of a specific medicine”, then it is not considered a “medical advertisement” under the Medicines Act and the MNZ Code.

A press release about the approval of a new medicine or the approval of a new indication of an approved medicine is permitted in New Zealand. There are no legal restrictions on the target audience.

A press release constitutes a “medical advertisement” under the Medicines Act, and therefore must: 

• include the mandatory information required under the Act; and 
• comply with the applicable advertising restrictions and prohibitions required under the Act.

A press release concerning the availability of an unapproved medicine or the off-label use of an approved medicine is unlawful in New Zealand. 

Comparative advertising is allowed in New Zealand, provided that the following conditions are met:

• the advertisement is not misleading; 
• the representations and claims made in the advertisement can be substantiated;
• any claim of comparative efficacy or safety must not be solely based on a comparison of the product’s data sheet, unless a head-to-head clinical study was conducted; and
• the advertisement otherwise complies with the general restrictions and prohibitions under the Medicines Act and New Zealand’s consumer protection laws.

Comparative advertising in relation to prescription medicines is generally not used in direct-to-consumer medical advertisements in New Zealand because it is prohibited by the MNZ Code. While compliance with the MNZ Code is voluntary, the compliance rate is high because compliance is a requirement under a subsidy and listing agreement with Pharmac and a condition of MNZ membership. 

The Medicines Act prohibits “advertising the availability” of unauthorised medicines or off-label use (unauthorised indications, patient age group, dosage or method of administration) of approved medicines, unless one of the limited exceptions under the Act applies. 

“Availability” is not defined in the Act. Established court decisions suggest that “availability” is not limited to the unapproved medicine being obtainable or accessible for use at the time of, or immediately after, the advertisement is issued, but includes notifying or advising that an unapproved medicine can be used or obtained irrespective of whether the medicine can be used or obtained at the time of the advertisement. The statutory prohibition against promoting or advertising an unapproved medicine is therefore broad and a fundamental pillar of New Zealand’s therapeutic product regulatory regime. 

Under the Medicines Act, there are very limited circumstances in which it would not be an offence to provide information concerning an unauthorised medicine or an unauthorised indication by a pharmaceutical supplier. The provision of such information must be directly connected with one of the following. 

• Named-patient exception: the supply of an unapproved medicine to an HCP at the HCP’s request (which must be unsolicited by the pharmaceutical supplier) for the sole purpose of treating a particular patient under that HCP’s care.
• Clinical trial exception: the supply of an unapproved medicine for an approved clinical trial.

These are the most commonly relied on exceptions.

There is no general exception to the broad prohibition against advertising the use or supply of unauthorised medicines or advertising unauthorised indications of an approved medicine in the Medicines Act that would permit the provision of that information at scientific conferences. 

However, the MNZ Code provides that information concerning a medicine or indication prior to registration receiving regulatory approval may be provided to healthcare professionals as part of the legitimate exchange of medical and scientific information, and without any promotional purpose or intent, by medical, regulatory or market access personnel. This includes, but is not limited to, scientific congresses, scientific exchanges and advisory boards.

Registered HCPs are permitted, under an exception in the Medicines Act, to prescribe, supply and administer an unapproved medicine or off-label use of an approved medicine for a named patient under their medical care. 

However, there is no corresponding exception to the prohibition on the advertisement of unauthorised medicines or unauthorised indications that would permit the proactive provision of unsolicited information relating to the availability of unapproved medicine or off-label use to HCPs. The MNZ Code reiterates this position stating that pharmaceutical companies must not advertise the availability of unregistered products or indications. 

In circumstances where the HCP makes an unsolicited request for information concerning an unapproved medicine or off-label use to a pharmaceutical company, the MNZ Code permits the company’s medical department to respond. To the extent any further information that is not specifically requested is provided, or is provided by a department that is not the company’s medical department (for example by the marketing department), this could be considered “advertising the availability” of an unapproved medicine or off-label use (as the case may be) in breach of the Medicines Act.

The MNZ Code permits the provision of information concerning an unapproved medicine or off-label use to government agencies or public health officials responsible for healthcare planning (eg, Te Whatu Ora ‒ Health New Zealand, Medsafe, the Ministry of Health or Pharmac). The information needs to be directly relevant to the preparation of budgets and not be provided for the purpose of promoting future market approval of a therapeutic product to avoid contravening the Medicines Act. 

There is no general exception to the prohibition on advertisement of unauthorised medicines or unauthorised indications in the Medicines Act that would permit advertising the availability of an unapproved medicine or off-label use in the context of publications relating to compassionate use programmes or other forms of early access. 

The existence of a compassionate use programme and a pathway to early access of an unapproved medicine can be published generally, provided that there is no specific mention of the investigational medicine itself or information relating to that medicine. 

In New Zealand, due to the broad statutory prohibition set out in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, specific information relating to the availability of a compassionate use programme or early access to an investigational medicine relies on patients being informed by their HCP, and the HCP and the pharmaceutical supplier rely on the “named patient” exception to exchange information relating to investigational treatments and the supply of the investigational medicine for the treatment of the named patient. 

Advertisements of prescription and over-the-counter medicines to the public must not, directly or by implication, claim that the medicine: 

• is infallible; 
• is or has been used or recommended by an HCP; or
• has beneficially affected the health of a particular person or class of persons, whether named or unnamed, and whether real or fictitious, referred to in the advertisement. 

Medical advertisements distributed solely to HCPs are exempt from some of these restrictions.

Advertisements for prescription medicines must include: 

• the words “Prescription Medicine”; 
• the name and quantitative particulars of each active ingredient; 
• statements regarding the potential risks and benefits; 
• a statement specifying how the consumer can find further information regarding the risks and benefits of the medicine; and
• the name and address of the sponsor.

It is industry practice to direct consumers to the Consumer Medicine Information (CMI) on Medsafe’s website or another official forum relating to the sponsor of the medicine.

Advertisements for restricted medicines must include the words:

• “Available only from your Pharmacist” or “Your Pharmacist’s advice is required”;
• “If symptoms persist see your Doctor/Healthcare professional”;
• “Use only as directed”;
• “Always read the label”;
• the name of each active ingredient; and
• if relevant, any required warnings issued by the Ministry of Health. 

Pharmacy-only and general sale medicines have similar requirements to restricted medicines, but the statement “Available only from your Pharmacist” is not required.

Advertisements must also comply with the general restrictions and prohibitions under the Medicines Act, including that the medicine cannot be promoted as a cure, the advertisement must not contain any patient testimonial or imply that it has been recommended by an HCP.

Under the MNZ Code, advertisements for prescription medicines must include a statement regarding the public funding status of the product and any funding restriction. For example, if a medicine is funded for only certain indications, then it is industry practice to state those funded indications. Similarly, if a medicine is unfunded, then that should also be stated.

Pharmaceutical companies can interact with patients and patient organisations. All interactions must be ethical, fair and transparent. The primary objective of the interaction must be to enhance the quality and use of medicines and improve health outcomes for patients.

The principal rules include the following.

• Financial or non-financial support may be provided for “bona-fide/legitimate patient organisation programmes”. Examples include patient market research surveys, disease awareness campaigns, and patient education programmes and materials. Support must not be offered or provided in a manner or on conditions that would interfere with the independence of the patient organisation and its members.
• The pharmaceutical company may contribute funding (or be the sole funder) for a patient organisation (or any of its programmes), but it cannot request or require that it be the sole funder. General obligations also apply in regard to the method of funding. For example, all financial payments or other contributions must be made directly to the patient organisation and not to any individual patient, and the terms of the funding arrangement must be fully documented in writing prior to any payment or contribution being made.
• A pharmaceutical company may sponsor patients to attend third-party educational events, provided the sponsorship payments are made to the patient organisation and not directly to the patient. Pharmaceutical companies must have no direct involvement with the patients who are to benefit from the sponsorship.
• A pharmaceutical company may engage a patient to perform a professional service, for example to provide insights into living with a disease or challenges facing patients and their families in managing chronic illnesses. The pharmaceutical company must not request or require the patient to perform any services in exchange for the patient recommending or promoting the company’s therapeutic product. 
• Any advertising or promotional material intended for viewing or distribution to the members of patient organisations must comply with the advertising requirements and restrictions set out in the Medicines Act and its regulations.

Advertising of prescription medicines directed solely at HCPs must (with limited exceptions) include the mandatory information prescribed by the Medicines Regulations set out below:

• the classification of the medicine; 
• the name of each active ingredient; 
• the appropriate quantitative particulars of each active ingredient; 
• a statement of the purpose for which the medicine is intended to be used; 
• a statement of the appropriate precautions to be taken in the use of the medicine; 
• information on the effectiveness and limitations of the medicine;
• a statement of any restriction imposed on distribution; 
• the dosage regime and mode of administration, or method of use, of the medicine; 
• a statement of any contraindications to the use of the medicine;
• information on the likely potentiating effects and interactions with other substances, medicines or environmental influences; and
• a statement of the known or likely poisonous effects of, or adverse reactions to, the medicine;

but must not include:

• a statement (based on the citation of a report) relating to the effectiveness or safety of the medicine that omits relevant parts of the report, or quotes from the report in such a way that another meaning to that intended by the report is conveyed; 
• an unsubstantiated comparison with other medicines; 
• data, previously considered valid, but made obsolete or false by subsequent findings; or
• a statement of the use of the medicine, or the dosage of the medicine, that contravenes any condition of a approval given under Section 20, 23, or 24 of the Medicines Act.

Where the advertisement is for a medical device, a description of the device and its uses, applicable precautions for use and any contraindications to use must be provided.

There is no restriction on the inclusion of the price in an advertisement directed solely at HCPs. Pharmaceutical suppliers must comply with the Commerce Act 1986 that prohibits a supplier from prescribing the price for resale by wholesalers or retailers, although exceptions apply in relation to the supply of therapeutic products to Pharmac as discussed in 9.6 Restrictions on Rebates or Discounts to Healthcare Professionals or Healthcare Institutions. 

The MNZ Code requires all advertisements and promotional material to include a clear and prominent statement about whether or not the product is listed on the Pharmaceutical Schedule (the list of products funded by Pharmac), and any funding restrictions that apply.

The MTANZ Code requires, in connection with advertising to HCPs, compliance with the ASA Code and relevant laws and regulations of New Zealand, and to reflect a high standard of social responsibility and conform to generally accepted standards of good taste.

In New Zealand, the Medicines Regulations require a Data Sheet to be provided to Medsafe with any application for market approval for a prescription or restricted medicine. This is New Zealand’s equivalent to the European “Summary of Product Characteristics”. 

Provided the applicable requirements for medical advertising described in 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public, 4.2 Information Contained in Pharmaceutical Advertising to the General Public and 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals (in relation to advertising to the general public and HCPs) are met, a medical advertisement can reference data on file or data generated from other clinical studies that is not included in the data sheet for that medicine. However, the data on file must not be relied on exclusively to substantiate a therapeutic claim, unless the data is part of the approved registration package. 

Further, a medical advertisement should not contain any statement that may be misleading or make unsubstantiated claims under the Fair Trading Act 1986. For example, advertising should not contain extracts from information arising from clinical studies that gives a false impression of the efficacy of the medicine by referring only to instances of positive results which are not representative of clinical findings overall in relation to the relevant medicine. Representations in advertising must be true and able to be substantiated.

Advertising that is misleading or deceptive, or likely to mislead or deceive, or includes unsubstantiated representations, will breach the Fair Trading Act.

In circumstances where two or more approved medicines are to be packaged and marketed together the combination will be a “New Medicine” under the Medicines Act and consent must be obtained from Medsafe for the combination product. 

There is no regulation in New Zealand specifically relating to the advertising of combination products, or of medicines with companion or complimentary diagnostics. Where medical advertising relates to combination products (a product that is a combination of any of a medicine, a medical device and/or a related product under the Medicines Act), the requirements set out in 4.1Main Restrictions on Advertising Pharmaceuticals to the General Public, 4.2 Information Contained in Pharmaceutical Advertising to the General Public and 5.1Restrictions on Information Contained in Advertising Directed at Healthcare Professionals must be met in relation to the combination product, if marketed together as a single product, and otherwise in relation to each advertised component product. 

Companion diagnostic products are not specifically referred to in New Zealand legislation but will typically be medical devices under the Medicines Act. Advertising of medical devices must comply with the requirements and prohibitions under the Medicines Act and Medicines Regulations, namely, it must:

• include the prescribed mandatory information on the advertisement itself; 
• ensure the advertisement reflect a high standard of social responsibility and conform to “generally accepted standards of good taste”; 
• not suggest the product or any component of the product is a cure or recommended by an HCP; 
• not include any patient testimonials; and
• not suggest that the product or any component of the product is endorsed by any government agency (eg Pharmac, Medsafe or any advisory or technical committee constituted for the purpose of considering the safety or efficacy of a medical device). 

Unlike other jurisdictions, New Zealand does not currently require market approval to be obtained prior to a medical device being sold, supplied or distributed in New Zealand. New Zealand does require the medical device to be registered on the Web Assisted Notification of Devices (WAND) Database within 30 days of the device being sold, supplied or distributed in New Zealand. The WAND Database is not an approval system for medical devices, but a notification to Medsafe of the device’s entry into the New Zealand market. 

There is no provision in the Medicines Act or Medicines Regulations specifically restricting provision of access to reprinted journal articles to HCP. 

The Medicines Code provides that the interpretation and conclusions in reprints of journal articles (and certain other material) distributed to HCPs that are used in promotions must be consistent with the Data Sheet and be used in a fair and balanced manner. The article must be presented without highlighting or being otherwise modified. 

Where a reprint of a journal article concerning a pharmaceutical company’s therapeutic products is provided to HCPs in New Zealand, the reprint is being used to promote the sale of the product and will be regulated as a “medical advertisement” in New Zealand. The reprint would therefore need to be compliant with the requirements and prohibitions set out in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionalswhen published in New Zealand. This is required even if the article was compliant in the jurisdiction of its original publication.

The provision of information by a medical science liaison will generally be subject to the same regulation under the Medicines Act and associated regulations relating to a medical advertisement provided to an HCP in any other capacity as set out in 5.1Restrictions on Information Contained in Advertising Directed at Healthcare Professionals. 

As discussed in 3.3 Provision of Information to Healthcare Professionals, a pharmaceutical company’s “medical department” may provide a response where an HCP makes an unsolicited request for information concerning an unapproved medicine or off-label use. This exception would apply to any medical science liaison in their capacity as an employee in the medical department of a pharmaceutical company engaging with an HCP. 

To the extent any further information that is not specifically requested is provided, or is provided by a department that is not the company’s medical department (for example by the marketing department), this could be considered “advertising the availability” of an unapproved medicine or off-label use (as the case may be) in breach of the Medicines Act.

Medical advertisements do not require prior authorisation or notification to Medsafe as a pre-requisite to publication. 

In practice, pharmaceutical companies will commonly have their advertising and promotional materials pre-vetted and approved by the Association of New Zealand Advertisers (ANZA) using its Therapeutic Advertising Pre-vetting System (TAPS), as required by the MNZ Code and MTANZ Code. 

This is an entirely voluntary process and while it does not constitute regulatory approval of the medical advertisement, Medsafe does, as a matter of general practice, look to whether the advertisement has TAPS approval when undertaking general market review to ensure industry compliance with New Zealand’s therapeutic advertising requirements. 

There is no statutory requirement to adopt a standard operating procedures, but this is recommended practice under the MNZ Code and generally utilised by the industry. Further, utilisation of the TAPS pre-vetting system is also often used to achieve regulatory compliance, as discussed in 6.1 Requirements for Prior Notification/Authorisation of Advertising Materials. 

The same laws and regulations that apply to “traditional” forms of medical advertising apply to all forms of online advertising.  

Unfortunately, the Medicines Act has significantly fallen behind technological developments, so applying the traditional promotional rules to social media and other types of online advertising can be challenging. It also raises an array of issues, including when a sponsor may be responsible for user or AI generated content, and how to communicate information on character-limited platforms to ensure regulatory compliance.

The MNZ Code contains specific guidance on online advertising, some of which is not entirely consistent with the (outdated) requirements of the Medicines Act. Some examples include the following.

• The MNZ Code permits the use of “click-throughs” to the substantive website to fulfil the mandatory information requirements for both direct-to-consumer and direct-to-HCP advertisements to accommodate the use of Google AdWords and posts on social media platforms that are subject to word limits. However, the Medicines Act regards the Google AdWord and the social media post as a separate advertisement, in and of itself, so the failure to include the necessary mandatory information would technically be regarded as a breach of the Medicines Act. 
• The MNZ Code permits the use of a “short-form” mandatory information for direct-to-HCP advertisements if the advertisement is designed to remind the healthcare professional of a therapeutic product’s existence, but cannot include therapeutic or promotional claims. The Medicines Act does not specifically allow for the use of “short-form” mandatory information, but the Act does specific separate mandatory information requirements for direct-to-HCP advertisements. 
• Where an embedded link or similar will take the consumer or HCP to a website hosted in another jurisdiction, a pop-up disclaimer, or similar, must clearly communicate that the viewer is leaving the local New Zealand company website to another site that the local company has not developed and which may not be consistent with New Zealand legislation or advertising codes. The mere use of a disclaimer does not necessarily remove the pharmaceutical advertiser’s liability for the medical advertisement under the Medicines Act, even if it is directed to an overseas audience and complies with the laws of the relevant overseas country.

The rules for advertising and promotion of prescription medicines to HCPs are generally similar to those that apply to direct-to-consumer medical advertisements. As such, companies are not legally required to restrict access to webpages that are intended for HCP only, so long as the mandatory information and the restrictions that apply to both direct-to-consumer and direct-to-HCP advertisements are complied with. 

However, there are some restrictions and prohibitions that apply to direct-to-consumer advertising but do not apply to medical advertisements that are directed to HCPs. For example, patient testimonials and recommendations made by HCPs are prohibited in advertisements directed to consumers, but permitted if distributed solely to HCPs. Webpages that contain these types of content would need to be restricted to healthcare professionals only to avoid breaching the Medicines Act. 

Disease awareness information that does not promote the sale of a medicine can be distributed to the general public on any online forum. There are no prescribed legal requirements governing its content or manner of distribution, other than ensuring that the content is not false or misleading (including by omission) and any claims can be substantiated. 

There is no legislation in New Zealand specifically relating to virtual scientific meetings or in-person scientific meetings. 

Industry codes will apply to relevant member organisations to regulate sponsorship of scientific meetings, or sponsorship of attendance, including those undertaken in a virtual setting. 

Applicable industry codes are the MNZ Code, in relation to medicines, and the MTANZ Code in relation to medical products, technologies and related services and therapies. These Codes have no legal status, but voluntary compliance is generally high among members and non-members. 

MNZ Code 

The MNZ Code requires information provided on the internet or via mobile media platforms or apps intended only for use by HCP to be accessible only by secure systems that prevent access by the general public. 

In other respects, virtual scientific meetings will be subject to the same overriding principles and provisions that apply to in person meetings. For a discussion of the sponsorship of scientific meetings see 9.3 Sponsorship of Scientific Meetings.

MTANZ Code

The MTANZ Code allows virtual third-party or educational events that may include the filming of presentations, panel discussions or live clinical procedures broadcast to an audience not physically present. Virtual events may be standalone, virtual training or promotions to HCPs. Such events must be relevant to the attending HCPs and comply with a detailed programme for the event provided in advance. Supporting material must be consistent with the programme and compliant with the Code. Home delivery hospitality is not permitted in connection with the event. In other respects, the event, and any related sponsorship, must comply with the Code in relation to scientific events generally as discussed in 9.3 Sponsorship of Scientific Meetings.

Prescription only and over the counter medicines can be advertised on social media platforms. Refer to 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public, 4.2 Information Contained in Pharmaceutical Advertising to the General Public and 7.1 The Advertisement of Medicinal Products on the Internet for the requirements for advertisements of prescription-only and over-the-counter medicinal products, including on social media.

Pharmaceutical companies are responsible for all content and communications published on their social media pages. The medical advertising rules and restrictions under the Medicines Act apply to any person that may “publish” or “cause or permit to be published” any medical advertisement, whether online or using traditional promotional platforms. 

Under the MNZ Code, personal use of social media by a company employee that potentially identifies them as a company employee, or that otherwise references their employer’s interests, may still be perceived as advertising or promotion of a product for which the employer company may be liable. 

Any social media activity that may be reasonably perceived as advertising or promotion must be accurate, truthful and comply with the MNZ Code. This responsibility falls on the pharmaceutical company. A disclaimer that the views expressed are the employee’s own, and not their employer’s, does not necessary exempt the pharmaceutical company from liability if the employee’s statement contravenes the advertising requirements and prohibitions under the Medicines Act. 

It is an offence under the Crimes Act 1961 to corruptly (with dishonest intention) give or offer bribes to a public official, including to any member or employee of any local authority or public body in their official capacity, with intent to influence the official. Any valuable consideration or benefit is a bribe for the purposes of the legislation. 

This means it is an offence, for example, to attempt to influence procurement decisions of employees of public hospitals in relation to the purchase of therapeutic products by means of providing or offering to provide a valuable gift to that employee. 

The relevant bribery offences apply in relation to bribes to individual public officials and not in relation to benefits provided to organisations. 

New Zealand’s public sector procurement rules reflect this legislative position. 

In the private commercial context, it is an offence under the Secret Commissions Act 1910 for any person to corruptly give a gift to an agent (or to certain relatives or other person at the agent’s request) as an inducement or reward for doing any act in relation to the principal’s business or affairs. Offences relate to gifts or consideration given to agents which can include companies and other entities that operate as agents for a principal. The Act operates to prohibit individuals from receiving secret bribes and kickbacks for recommending or selling therapeutic products. 

The Crimes Act and Secret Commissions Act are enforced by the Serious Fraud Office and the New Zealand Police.

The rules relating to the provision of benefits or other inducements to prescribe offered to HCPs and healthcare organisations are largely contained in industry codes, which represents New Zealand’s pharmaceutical industry’s self-regulation of the issue. Applicable industry codes are the MNZ Code, in relation to medicines, and the MTANZ Code in relation to medical products, technologies and related services and therapies. 

All interactions between pharmaceutical companies and HCPs are required by the MNZ Code to be able to successfully withstand public and professional scrutiny and conform to professional and community standards of ethics and of good taste. 

The MTANZ Code includes among its values that medical technology companies conduct business with integrity at all times, and avoid real or perceived conflicts of interest with HCPs. 

Each of these Codes prohibit inducements to prescribe, and permit the provision of gifts and benefits only for purposes that do not compromise the independence of the HCP and healthcare organisations to prescribe without influence by inducements (as discussed further in section 9. Gifts, Hospitality, Congresses and Related Payments).

While the current Medicines Act is silent on the issue of improper inducement of an HCP by a pharmaceutical company, the Therapeutic Products Act 2023 covers this issue by making it an offence for a pharmaceutical company or a supplier of a therapeutic product to give or offer to give a benefit to an HCP with the intention of: 

• inducing the HCP to make a “favourable clinical decision” about a therapeutic product; or 
• rewarding the HCP for making such a decision. 

The new coalition government has stated that it will repeal the Therapeutic Products Act, so whether or not this regime will be replicated in any new replacement legislation remains to be seen. 

Offering gifts to HCPs is generally permitted under New Zealand law but industry codes restrict the practice and anti-bribery legislation (as discussed in 8.1 Anti-bribery Legislation Applicable to Interactions Between Pharmaceutical Companies and Healthcare Professionals) applies to restrict or prohibit gifting in some circumstances. 

The MNZ Code prohibits gifts to healthcare professionals unless they fall within specified criteria. Permitted gifts include items of medical utility, certain stationery items, educational material directed to HCPs or patients, prizes for competitions meeting specified criteria and sponsorship of attendance, or hospitality, at educational events (as discussed further in 9.3 Sponsorship of Scientific Meetings). 

The MNZ Code prohibits gifts to charities or societies being offered to HCPs as an incentive to visit trade display stands. 

Hospitality (food and beverages) provided to HCPs must be secondary to the medical education or the business purpose of the pharmaceutical company organised meeting and cannot include entertainment. Meals and beverages may be provided only to the extent appropriate for the content and duration of the meeting and must not be excessive. 

Reimbursement of expenses incurred by the HCP in relation to the HCPs attendance at the medical education event or other meeting organised by the pharmaceutical company is permitted, provided that: 

• the expense incurred was anticipated and agreed in the relevant contractual agreement; and 
• bona fide receipts are provided.

Gifts and other benefits cannot be provided or offered to HCPs as an inducement to recommend, prescribe, dispense or administer the pharmaceutical company’s products. 

The provision of samples or starter packs of therapeutic products to HCPs is permitted under the Medicines Act and its regulations, provided the samples themselves meet all regulatory requirements. Supply by way of gift or sample for the purpose of promoting a sale is treated as a sale under the Medicines Act. Samples must therefore meet the applicable requirements of sale, supply and distribution in New Zealand, including approval from Medsafe and labelling.

The MNZ Code requires samples of prescription medicines to be given only to HCPs with appropriate prescribing rights and prohibits the sale or trading of samples. Samples cannot be provided for the HCP’s own use or made available at professional trade display stands. Samples must be for registered medicines and indications, and otherwise be in compliance with regulations. Quantities provided must correspond to quantities usually prescribed by the relevant HCP and the HCP must not be pressured into accepting samples. 

Sales representatives must hold or be nominated on the company’s Hawker’s licence when carrying or issuing samples or starter packs. The MNZ Code specifies requirements for record keeping, delivery and returns processes. 

Hospital requirements relating to distribution of samples must also be complied with. 

Sponsorship by pharmaceutical companies of, or of attendance at, scientific meetings and conferences is generally permitted by New Zealand law (subject to anti-bribery law as discussed above in 8.1 Anti-bribery Legislation Applicable to Interactions Between Pharmaceutical Companies and Healthcare Professionals). 

The MNZ Code requires speakers at events organised by pharmaceutical companies to be familiar with New Zealand registered indications for relevant products and restrictions on the promotion of unapproved products and off-label use.

Travel to scientific meetings may be provided to HCPs where it is relevant to their practice area and it is justified by the original location of the HCP. Travel by train, bus or taxi may be reimbursed at cost and use of a private vehicle can be reimbursed at the Inland Revenue Department recommended rate calculated be reference to the distance travelled. Flights must be booked by the sponsor (to mitigate the risk of transfer of tickets) and may only be reimbursed to the HCP if direct booking with the sponsor is not reasonably practicable. Travel for HCPs must be economy class within New Zealand. Business class may be used for international flights longer than five hours or if justified for medical needs. First-class travel for international flights is prohibited. Payment of an HCP’s reasonable and actual accommodation costs is permitted. 

Where pharmaceutical companies organise meetings overseas that a New Zealand resident HCP attends, the MNZ Code requires members to comply with whichever is the higher standard imposed by the MNZ Code or applicable local industry requirement in relation to the location, venue, hospitality, travel and accommodation arrangements.

New Zealand pharmaceutical companies are obliged to ensure affiliated companies outside New Zealand that sponsor meetings held in New Zealand are made aware of and comply with the MNZ Code. 

Sponsorship relating to attendance by HCPs at educational meetings organised by third parties (such as society, college, university or other HCP organisation) must be primarily for the purpose of enhancing the medical knowledge and quality use of prescription medicines in New Zealand. 

Financial sponsorship should be paid either directly to the third party or the HCP’s organisation, not to an individual HCP. 

Sponsorship cannot be conditional on, or interfere with the independence of, an HCP’s prescribing practices.   

Pharmaceutical companies may organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences under New Zealand law, subject to compliance with anti-bribery legislation and ethical standards set out in the MNZ Code. 

A key ethical standard of the MNZ Code is that any activity undertaken by the pharmaceutical company must not bring the pharmaceutical industry into disrepute. 

New Zealand law does not prohibit pharmaceutical companies from providing grants or donations to HCPs or healthcare institutions, provided the provision of the grant or donation does not breach New Zealand’s anti-bribery laws and comply with the ethical standards set out in the MNZ Code. 

The MNZ Code permits grants and financial assistance to HCPs and other healthcare institutions for one or more of the following purposes:

• education or academic training;
• medical research; or
• activities that improve the quality use of medicines or improve patient outcomes, eg, a clinical audit programme.

Donations of items of medical utility to improve patient care and quality use of medicines is permitted. The item must be of modest monetary value and should only be offered occasionally. 

The MNZ Code specifically permits donations of medical textbooks and medical education software but prohibits gifts of common electronics, common medical equipment, common storage items and business management software.

Medical items may be branded but should not bear the name of any medicine unless necessary for the safe use of the item. 

Donations must not be conditional on HCP’s fulfilling obligations relating to any therapeutic product, or compromise the independence of an HCP’s prescribing or dispensing practice. 

The MNZ Code prohibits cash or cash equivalent (such as gift cards) donations being offered to HCPs, either directly or indirectly. The provision of cash or equivalent payments can create a potential appearance of impropriety or conflict of interest. 

Rebates and discounts can be offered by pharmaceutical suppliers to HCPs and healthcare institutions, provided the offer, arrangement or understanding does not constitute a restrictive trade practice prohibited by the Commerce Act 1986, namely:

• practices that substantially lessen competition in a market; 
• price fixing; 
• practices that take advantage of market power; 
• resale price maintenance; and
• cartel conduct. 

New Zealand’s competition law regime is unique in that Pharmac is exempt from certain restrictive trade practices that would otherwise apply in normal circumstances to prohibit the rebate or discount. 

The statutory exemption allows Pharmac to enter into, and give effect to, agreements for the purchase of pharmaceuticals without having to comply with the restrictions and prohibitions under Part 2 of the Commerce Act. 

For example, under the exemption, Pharmac can enter in any contract, understanding or arrangement that has the purpose and the effect of substantially lessening competition in a market. The New Zealand court has confirmed that this exemption also extends to the pharmaceutical company that is engaging in commercial negotiations with Pharmac with a view to obtaining a listing agreement with Pharmac. 

Pharmaceutical companies may pay for services provided to them by HCPs. 

The MNZ Code allows payment for services not exceeding fair market value (as well as reimbursement for the reasonable costs of related expenses) to be paid to a consulting HCP. Such arrangements must not include entertainment or recreation. 

Consulting services of an HCP must only be retained where a legitimate need has been identified and properly documented.   

No prior regulatory authorisation or notification is required in relation to any of the activities described in 9. Gifts, Hospitality, Congresses and Related Payments.

In New Zealand, there are currently no statutory “sunshine” or transparency requirements in relation to the disclosure of transfers of value (cash or other benefits) between a pharmaceutical company and an HCP or healthcare organisation.

In 2021, MNZ introduced guidelines (the “Guidelines”) for the disclosure of transfer of value to HCPs. The Guidelines only apply to MNZ members and, even then, compliance is voluntary for members.

For HCPs, their relationship with pharmaceutical companies may cause a conflict of interest, which they must manage in accordance with their relevant codes of ethics and practice. The Medical Council of New Zealand’s Statement on Doctors and Health-Related Commercial Organisations and the New Zealand Medical Association’s Code of Ethics only require the HCP to disclose a transfer of value from a pharmaceutical company to that HCP if that transfer of value constitutes an actual or potential conflict of interest.

As discussed in 10.1 Requirement for Pharmaceutical Companies to Disclose Details of Transfers of Value, industry codes of practice mainly regulate the financial relationship between pharmaceutical companies and HCPs. The MNZ Code and Guidelines only apply to member companies, and compliance with the Guidelines is voluntary. 

Non-members (including foreign companies and companies that do not yet have products in the New Zealand market) can voluntarily comply with the MNZ Code and Guidelines as a matter of “best industry practice”.

Generally, legislation prohibiting bribes and kickbacks will also apply to foreign companies and companies that do not yet have products on the New Zealand market if the offending conduct occurred in New Zealand. 

Medsafe is the regulatory authority that is responsible for administering the Medicines Act and associated regulations in New Zealand. The Investigation and Enforcement Team of Medsafe conducts investigations under the Medicines Act, including in relation to breaches of pharmaceutical advertising and labelling requirements. 

The Commerce Commission is the crown entity that enforces consumer law including the Fair Trading Act 1986 (FTA) that prohibits, among other things, misleading and deceptive conduct in trade including in relation to the advertising of pharmaceuticals. 

In addition, New Zealand’s pharmaceutical industry is self-regulated by industry groups such as MNZ, the MTANZ, and the Advertising Standards Authority (ASA), each of which require compliance by members of their respective codes of practice. 

Complaints may be lodged, including by competitor pharmaceutical companies, in relation to advertising infringements of the Medicines Act (or related legislation) with Medsafe’s Investigation and Enforcement Team.

Similarly, complaints relating to breaches of consumer law may be lodged with the Commerce Commission. 

Complaints may also be lodged with relevant industry groups, such as MNZ, where the alleged offender is a member. Such complaints may be brought by members and non-members for behaviour that infringes the relevant industry code. 

New Zealand law does permit private prosecutions in certain narrow circumstances, and the initiation of such proceedings is fairly rare in New Zealand. In practice, complaints to the regulator are the most common form of alerting the regulator to contraventions of the law.

Sanctions that may apply to pharmaceutical companies that breach the Medicines Act or its regulations are:

• NZD1,000 for failure to include the name and business address of the advertiser;
• for any other offence under the Medicines Act, a term of imprisonment of up to three months (for company director) or a fine not exceeding NZD500 (for both the company and its directors);
• for continuing offences, a further fine of up to NZD50 per day or part day that the offending continues;
• for offences under the Medicines Regulation, a fine of up to NZD500; and 
• the court may also order forfeiture of medicines, medical device, advertising or other material and associated packing or withdrawal of the therapeutic product from circulation in certain circumstances.

Advertisers that breach the Fair Trading Act are subject to a fine for each offence of up to NZD200,00 for an individual and NZD600,000 for a body corporate.

The penalties for breaches of the Commerce Act in relation to restrictive trade practices are:

• in relation to the company director, a fine of up to NZD500,000; and 
• in relation to bodies corporate, a fine of up to the greater of NZD10 million or three times the resulting commercial gain or, where this cannot readily be established, 10% of the turnover of the offending body corporate and all interconnected bodies corporate. 

The penalty under the Crimes Act 1961 for bribery of an official, and also for any breach of the Secret Commissions Act 1910, is a term of imprisonment not exceeding seven years for company directors. 

Industry bodies have their own sanctions regime for code breaches.

Procedures before or measures taken by self-regulatory bodies are unrelated to procedures or measures taken before any court in New Zealand. 

Complaints made with self-regulatory bodies do not prevent the same complainant from pursuing the same matter with Medsafe, the Commerce Commission, or any other regulator (and vice versa). 

In recent years, Medsafe’s pharmaceutical advertising enforcement activities have been largely focused on content published on digital platforms. While the making of an unsubstantiated or false or misleading therapeutic claim remains a common issue driving Medsafe’s investigatory and enforcement actions, the “global” nature of online platforms can often raise complex questions relating to jurisdiction. 

For example, a medical advertisement that is targeted at an overseas audience that is not compliant with New Zealand laws but compliant with the local laws of the relevant overseas country may still be subject to New Zealand laws if the advertisement “originates” in New Zealand and can be seen by New Zealand patients (despite but not targeted at them). 

There is no specific legislative guidance for how this is determined to establish jurisdiction under the Medicines Act and its associated regulations. Instead, Medsafe’s response to the issue appears to be mostly driven by the specific facts surrounding the conduct, including the steps the pharmaceutical advertiser has taken to mitigate against the risk that the non-compliant medical advertisement could be seen by New Zealand patients. 

This tends to be a particularly problematic area for New Zealand’s dietary supplements industry where their major consumer market is the United States of America. 

Patient safety continues to be a fundamental priority of Medsafe. In 2023, Medsafe investigated the following companies.

• Tric Nutrition was investigated for supplying dietary supplements that contained quantities of certain active ingredients in excess of the permitted level to be a lawful dietary supplement and, instead, was considered by Medsafe to be at a therapeutic level and therefore the product should be regulated as a medicine. As a result of Medsafe’s investigation, Tric Nutrition withdrew 15 products from its range. 
• Telehealth service provider, Burst Health, was investigated for advertising prescription weight loss medicines on social media platforms without complying with direct-to-consumer advertising requirements and also a controller drug, which should not be advertised directly to consumers. At the date of writing, Medsafe’s investigation remains ongoing. 

The Ministry for Primary Industries (MPI) is responsible for regulating the advertisement of authorised veterinary medicines. Authorised products include trade name products with an agricultural compounds, including veterinary medicines (ACVM) registration number, and products authorised by exemption from registration.

The advertising of veterinary medicines is regulated under:

• the Agricultural Compounds and Veterinary Medicines Act 1997 (the “ACVM Act”); 
• the Veterinarians Act 2005;
• the Code of Professional Conduct for Veterinarians; and
• the Fair Trading Act.

All agricultural compounds must be authorised under the ACVM Act before they can be sold, supplied, distributed and promoted in New Zealand.

It is common for MPI to require, as a condition of authorisation, that any advertisement relating to the veterinary medicine does not: 

• misrepresent, mislead or make false claims about authorised product and manufacturing specifications; and 
• make false or misleading claims about the regulatory status of the product.

Other advertising requirements include: 

• the complete trade name of the product must be used in all advertising and promotional activities; 
• claims advertised must be consistent with those authorised for that product, including formulation ingredients and label information;
• testimonial claims may be used only if the information in the testimonial is consistent with authorised product claims;
• comparisons with other authorised products are permitted, provided the advertisement is consistent with claims of all authorised products in the advertisement;
• certain registered products that have conditions of registration that place controls, such as who can use it, where it can be used, or how it could be used, must be clearly state in the advertisements; and
• statements must not:

1. have claims that state or imply that MPI/NZ Food Safety/ACVM team guarantees the safety or efficacy of a product and their logos must not be used on advertising material; or
2. imply endorsement or approval from MPI/NZ Food Safety/ACVM team.

It is an offence under Section 55 of the AVCM Act to knowingly contravene any condition applied to the authorisation of a product, including any condition relating to its promotion. The MPI can require that the non-compliant party cease, withdraw or modify the advertisement to bring it into compliance. 

Suppliers of veterinary medicines can request the MPI to review proposed advertisements to ensure compliance. This is entirely voluntary and not a statutory pre-requisite to the publication of any advertisement.