Medicines New Zealand Incorporated Code of Practice

Transcription

1 Medicines New Zealand Incorporated Code of Practice Edition 15 October 2010 Page 1

2 Code of Practice, Edition 15 Effective from 1 January 2011 (The Code of Practice was first published in 1962). Page 2

3 Introduction Medicines New Zealand Incorporated is an industry association that represents the pharmaceutical companies in New Zealand. Medicines New Zealand Vision To improve health outcomes for New Zealanders through equitable access to quality medicines. Medicines New Zealand Mission To advocate for patients' needs by influencing public policy to achieve equitable access to quality medicines. The Medicines New Zealand Code of Practice (The Code) The pharmaceutical industry promotes the concept of good health and a positive, healthoriented approach to daily living. Recognising that prescription medicines play a vital role in the prevention, amelioration and treatment of disease states, the industry undertakes: To provide prescription medicines that conform to the highest standards of safety, efficacy and quality; To ensure that medicines are supported by comprehensive technical and informational services in accordance with currently accepted medical and scientific knowledge and experience; and To be ethical and professional in all interactions with healthcare professionals, public health officials and the general public. The industry is committed to the quality use of prescription medicines and responsible prescribing, and urges that its products be used only in accordance with the directions and advice of healthcare professionals. To ensure that information is available upon which to make informed prescribing decisions, it is necessary for companies to disseminate to healthcare professionals the specialised product information gained during the research and development process, and from experience gained in clinical use. In doing so, a company may draw attention to the existence and nature of a particular product by appropriate educational and promotional measures. With the full cooperation of the industry, there is now adequate legislation designed to ensure that all marketed products meet acceptable standards of quality, effectiveness and safety based on present knowledge and experience. While it is possible to legislate satisfactorily for the testing, manufacture and control of prescription medicines, appropriate standards of marketing conduct cannot be defined by the same means. For this reason, responsible manufacturers and distributors have concurred in the promulgation of the Code of Practice and submitted to its constraints. Members of the pharmaceutical industry have a responsibility to provide on-going, objective and scientifically valid interpretations of data Page 3

4 on prescription medicines to healthcare professionals. The industry also has an obligation to provide appropriate non-promotional and promotional information on prescription medicines to members of the general public. This Code represents an act of self-regulation. The Code sets out standards of conduct for the activities of companies when engaged in the marketing of prescription medicines used under medical supervision as permitted by New Zealand legislation. The purpose of the Medicines New Zealand Code of Practice (the Code) is to define and ensure high standards for the ethical and responsible promotion of prescription medicines in New Zealand, and wherever possible to exceed those required by law. The Code should be viewed as the minimum set of standards required to promote prescription products in New Zealand and does not in any way prohibit more stringent and comprehensive requirements being applied by individual companies. Acceptance and observance of the Code is a condition of membership of Medicines New Zealand. In accepting and observing the Code companies must comply with both the letter and the spirit of the Code. Companies should ensure that all agents acting on their behalf are fully conversant with the provisions of this Code. Pharmaceutical companies that are not members of Medicines New Zealand are invited to accept and observe this Code and must comply with its provisions when required by the Advertising Standards Authority. Medicines New Zealand may issue determinations from time to time for the purpose of interpretation of certain sections of the Code. A major guiding principle of the Code is that whenever a promotional claim is made for a product, it shall be accompanied by appropriate information consistent with the approved Data Sheet for that product. The Code also reflects the industry s commitment that all activities with, or materials provided to healthcare professionals and members of the general public must not bring discredit to, or reduce confidence in the pharmaceutical industry. Failure to comply with the Code will result in sanctions being applied under the provisions outlined in the Administration of the Code. Adherence to this Code in no way reduces a company s responsibilities to comply with the Commerce Act 1986, the Fair Trading Act 1986 and other requirements, legislation and Codes. If any person considering lodging a Code of Practice complaint is unsure of how to go about it, please see the Administrative section of this Code. For further queries on the complaints procedure, contact Medicines New Zealand on (04) Page 4

5 Contents 1. General Principles 9 Appropriate protocols or standard operating procedures 9 Spirit of the Code 9 Ethical standards 9 Professional status of the medical and other health professions 9 Generally accepted standards of good taste 9 Verbal communications 9 2. Legislative Requirements 11 Medicines should only be promoted for New Zealand approved indications. 11 Notification of Adverse Events 11 Other relevant legislation General Advertising and Promotional Activities 15 Responsibility 15 General Advertising Requirements 15 Promotional Claims 16 Comparisons 17 Data on File 18 Disparaging References 18 Personal Communication 18 Quotations 18 The word "new" 19 Company-sponsored publications 19 Advertorials 19 Endorsements 19 Electronic Media Promotion 20 Events/Programme Sponsorship Advertising Activities Directed at Healthcare Professionals 23 Advertisements to Healthcare professionals 23 Full advertisements 23 Short advertisement 24 Brand Name Reminder Items 24 Medical Literature and Reprints 25 Page 5

6 Reference Manual Advertising 26 Mailings (including Electronic Mail) 26 Professional Trade Displays 27 Interactions and Relationships with Healthcare Professionals 28 Company Educational Events 28 Competitions 29 Gifts and Offers 30 Grants/Financial Support 30 Donations to Improve the Health Services to Patients 31 Hospitality 31 Entertainment 32 Travel and Accommodation 32 Sponsorship of Health Care and Other Organisations 32 Sponsored Third-Party Educational Events 33 Consulting Arrangements with Healthcare Professionals 34 Sponsorship of Healthcare Professionals to Attend Medical Educational Meetings 34 Discredit to, and Reduction of, Confidence in the Industry Interactions and Relationships with the General Public and Health Consumer Organisations 37 Direct to Consumer (DTC) Advertising (i.e., DTCA) 37 Patient Education Materials 39 Patient Support Programmes 40 Consumer Trade Displays Media Relations 43 Media Releases Clinical and Market Research 45 General Provisions 45 Clinical Trial Guidelines 45 Product Familiarisation Programmes (PFP) 45 Market Research Corporate Responsibility 47 Administration of the Code 51 The Code of Practice Standing Committee 51 The Complaints Process 51 Sanctions 53 Page 6

7 Appeals 53 Publication of Breaches of the Code 55 Persistent Breaches of the Code 55 Review of the Code 55 Complaints Against Non-members 55 Discretion for Referral 55 Abuse of the Code 55 Monitoring 55 GLOSSARY 57 INDEX 63 Page 7

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9 1. General Principles 1.1 Companies should establish and maintain appropriate protocols or standard operating procedures within the company to ensure full compliance with and observance of the Code and to review and monitor all promotional activities and materials. 1.2 The Chief Executive of a New Zealand pharmaceutical company (i.e., the most senior person in the New Zealand local operating company, including Country Manager, Managing Director, etc) is primarily responsible for ensuring adherence to the Code. Companies should have sufficient internal and/or external resources to ensure adherence to the Code, and should ensure that all company personnel and agents acting on the company's behalf are cognisant of relevant provisions of this Code. 1.3 Companies must comply with the spirit as well as the letter of the Code. 1.4 Companies must ensure that they comply with the highest ethical standards, and must not misrepresent their products, or act in a manner likely to bring the pharmaceutical industry into disrepute. 1.5 The professional status of the medical and other health professions needs to be considered at all times in the course of promotional activities. Healthcare professionals names or photographs must not be used in a manner that is contrary to the relevant health profession Code of Ethics. 1.6 Wherever a healthcare professional s name is specified in any kind of promotional material, other than by citation of a published reference, the company should ensure that the individual specified is aware of and provides written approval for the use of his/her name in the context of the entire promotional material. For example, if a doctor agrees to introduce an educational video, they should be fully aware of the final content of that video, as such a situation would imply endorsement. The company should also obtain written approval from the individual if his/her name is used in subsequent promotional material. The potential for the healthcare professional to subsequently withdraw their approval for use of their name within said promotional material (i.e., after production and use of the promotional material) should be addressed in the pre-production agreement with the healthcare professional. 1.7 All company activities (including promotional and educational material) must conform to generally accepted standards of good taste and recognise the professional standing of the recipients. 1.8 Verbal communications carry the same implications as written ones, and as such must comply with the Code. Page 9

10 1.9 Company activities must not include anything that would be likely to cause serious or widespread offence, taking into consideration prevailing community standards as described in the rules on decency and offensiveness in the Advertising Standards Authority (ASA) Advertising Code of Ethics Review and Revisions of the Code - This Code will be reviewed, and if necessary updated, at minimum every three years. Medicines New Zealand will notify all members of any changes to the Code. Companies are responsible for ensuring that all personnel are applying the current version of the Code. Page 10

11 2. Legislative Requirements 2.1 Medicines should only be promoted for New Zealand approved indications. 2.2 Prior to or outside the regulatory approval process, provision of information should be limited to replying to unsolicited questions/requests for information. This information should be provided or approved by the medical department. 2.3 This Code does not intend to restrict the right of the medical and scientific community to access updated scientific information, nor does it preclude provision of data to clinical trial investigators or policy makers responsible for healthcare planning (e.g., DHBs, Ministry of Health or PHARMAC). The exchange of medical and scientific information by the medical /clinical department of a company during the development of a medicine is not prohibited provided that any such information or activity does not constitute proactive promotion, which is prohibited under this or any other section of this Code. Approved press releases and briefing materials are permitted, as are presentations of new data at scientific congresses and at Advisory Boards when appropriate. 2.4 Notification of Adverse Events - Companies must ensure they are aware of the requirements for the reporting of adverse events as outlined in Section 41 of the Medicines Act 1981 and from all appropriate agencies such as Medsafe of the Ministry of Health, the Standing Committee on Therapeutic Trials (SCOTT), the relevant institutional ethics review committees and the New Zealand Pharmacovigilance Centre (NZPhvC) including the Centre for Adverse Reaction Monitoring (CARM) and the Intensive Medicines Monitoring Programme (IMMP). The requirements of these bodies may change from time to time and it is not appropriate that they be listed here. 2.5 Companies must conform to all relevant legislation, including that listed below. Although all reasonable care has been taken to include all relevant legislation, this advice may not include all applicable legislation and is not intended to replace legal advice Medicines Act Part 2 of the Act regulates the approval process for medicines as well as dealings with medicines by manufacturers, wholesalers and packers of medicines. Sections of Part 2 address exemptions as they relate to authorised prescribers (S25), pharmacists (S26), veterinarians and optometrists (S27), herbal remedies (S28), medicines without consent to distribute (S29), and clinical trials (S30). Part 3 of the Act contains provisions relating to the granting of licences to manufacture, pack, distribute or sell medicines. Page 11

12 Part 4 is specific to medical advertisements, contains restrictions on medical advertisements and prohibits various types of misleading advertisements. The legislation on advertising medicines should be read in conjunction with the current Medicines Regulations sections on advertising Medicines Regulations 1984* - Part 3 of the Regulations is specific to Advertisements. Part 10 of the Regulations addresses Data Sheets and CMIs. Schedule 1 lists medicines scheduled as prescription, restricted or pharmacist-only medicines. * At the time of the review of this 15 th Edition of the Code, Medsafe was in the process of reviewing the Medicines Regulations Any changes that might impact on the Code will be notified as appropriate The Gambling Act This Act controls the conduct of games of chance, lotteries and prize competitions and limits the people who can run them. Companies may run prize competitions or lotteries as long as they are conducted as sales promotions schemes. There are various prohibited prizes in a lottery or prize competition, e.g. alcohol, firearms, land that is not zoned residential, second hand goods Commerce Act The Commerce Act prohibits certain restrictive trade practices including: - contracts, arrangements or understandings substantially lessening competition; - contracts, arrangement or understandings between competitors containing exclusionary provisions (i.e. group or collective boycotts); - pricing fixing between competitors; - abuse by a company of a dominant position in a market; and - resale price maintenance. The penalties for contravention under the Commerce Act are extremely severe Fair Trading Act There is civil liability if a company engages in misleading or deceptive advertising or promotions, or conduct that is likely to mislead or deceive. There is criminal liability if the advertising or promotion contains specified types of false or misleading representations. A promotion piece that is composed of statements that are each objectively factual, may nevertheless be unfair or misleading as a whole, taking into account all pertinent factors, including typography, layout and other printing features. Avoid ambiguities, out-of-context quotations, omission of facts, imbalance between information regarding effectiveness and information relating to adverse events and contraindications, or imbalance in comparisons involving competitive products. Page 12

13 2.5.6 Protection of Personal and Property Rights Act This Act prevents a guardian from consenting to a subject s enrolment in a medical experiment for any other reason than to save the person s life or prevent serious damage to health NZ Bill of Rights Act Section 10 of this Act states that every person has the right not to be subjected to medical or scientific experimentation without that person s consent Privacy Act The Act regulates the collection, storage, use and disclosure of personal information. Personal information must usually be collected from the individual concerned. At the time of collection a number of disclosures must be made to the individual such as the purpose of collection and rights of access and correction. Personal information obtained for one purpose cannot normally be used for another purpose. Also, disclosure of the information to a third party is restricted. 2.6 Other Legislation Certain sections of other legislation may be pertinent from time to time. These include: Health Practitioners Competence Assurance Act 2003 Misuse of Drugs Act and Regulations 1977 Consumer Guarantees Act 1993 Health and Disability Services (Safety) Act 2001 Hazardous Substances and New Organisms Act 1996 (HSNO Act) New Zealand Public Health and Disability Act 2000 Page 13

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15 3. General Advertising and Promotional Activities This section relates to all types of advertising and promotional activities. These general principles form the basis for the Code. It is also important to refer to the specific sections of the Code, as appropriate, for further guidance and clarification. 3.1 Responsibility It is the responsibility of companies, their employees and their agents to ensure that all promotional claims are fair and accurate. Medical claims must be consistent with the New Zealand approved Data Sheet This responsibility relates not only to the product being promoted, but also to any information given or claims made about other products or disease states or conditions. It also applies to tag lines and their ability to be substantiated If new product data are generated that significantly change the safety or efficacy information, e.g. new and reliable information indicate a serious previously unknown safety risk, all promotional material for that product must be reviewed and either revised as necessary or withdrawn. 3.2 General Advertising Requirements Advertisements and promotional material must comply with all relevant New Zealand legislation and codes of practice Advertisements and promotional material must include, as appropriate, the information required for Full and Short advertisements as outlined in Sections and 4.1.3, respectively All advertising and promotional material must be pre-vetted and approved by an Association of New Zealand Advertisers (ANZA) approved process, such as the Therapeutic Advertising Pre-vetting System (TAPS). This process includes review of the material by the TAPS adjudicator and/or Delegated Authority Advertisements and promotional material should be in good taste and must not bring the pharmaceutical industry or healthcare professionals into disrepute Advertising and promotional activities must not be deliberately disguised. (See also 3.11) The type size and graphics used in all advertisements and promotional material should be clear, legible and easily understood by the intended audience. The type size should be not less than 1.5mm, as measured by the height of the font s lower case e and should appear on a background sufficiently contrasting for legibility Advertisements and promotional material should provide balanced information on the benefits and risks of the product. Page 15

16 3.2.8 Advertisements and promotional material should not by implication, omission, ambiguity or exaggerated claim mislead or deceive or be likely to mislead or deceive consumers or healthcare professionals, abuse the trust of or exploit the lack of knowledge of consumers or healthcare professionals, exploit the superstitious or without justifiable reason play on fear Advertisements and promotional material should not imitate the devices, copy, slogans, or general layout adopted by other companies in a way that is likely to mislead or confuse Advertisements and promotional material should not have depictions that unduly glamorise the product or portray unrealistic outcomes Any scientific information in an advertisement or promotional item must be accurately presented. Scientific terminology should be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed. Therapeutic claims must be factual and adequately referenced Advertisements for Class A, B, and C controlled drugs as defined in the Misuse of Drugs Act 1975 must be directed at healthcare professionals only and in appropriate media. 3.3 Promotional Claims Promotional claim means any statement made by a company or company s representative, whether verbal or written, which conveys the positive attributes of a product for the purpose of encouraging the usage of that product. Promotional claims may extend beyond a simple non-qualitative or quantitative description of the therapeutic category or approved indication, and may include statements concerning efficacy, rate of adverse reactions, or other aspects of the product including comparative market information Exaggerated or all-embracing promotional claims must not be made and unqualified superlatives must not be used. Promotional claims should not imply that a medical product, or an active ingredient, has some special merit, quality or property, unless this can be substantiated and is referenced All promotional claims must be current, accurate, capable of substantiation and must not be misleading either directly, by implication, by scale or by omission. Graphics should not be used in any way which might mislead; for example, by their incompleteness or by the use of suppressed zeros or unusual scales Promotional claims must be based on an up-to-date evaluation of all relevant scientific evidence and should clearly reflect the balance of the evidence. Any information used to support a promotional claim that is not contained in the approved New Zealand Data Sheet must include sufficient detail and be of adequate quality to allow evaluation of the results. This information should not be based solely Page 16

17 on the findings of a single paper or study unless that paper fairly represents the balance of current scientific evidence All promotional claims must be clearly referenced. References cited in promotional material must be made available on request within 10 working days Quotations from medical and scientific literature should be accurately reproduced and the precise sources identified. The intended meaning of the author or clinical investigator, or the significance of the underlying work, should be accurately conveyed Use of the definite article to imply a special merit, quality or property for a medicine is unacceptable. For example, a claim that a product is The analgesic implies that it is in effect the best, and would not be acceptable In vitro or laboratory tests and trials in animals are not sufficient to substantiate a promotional claim. In vitro or animal models can only generate a hypothesis that the product may have some effect in humans. The limitations of extrapolating these data to humans must be made clear Adverse Effects - Any statement about adverse effects should be specific and consistent with the New Zealand approved Data Sheet in the first instance, or may be supported by published data to which references are given. It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency. Companies are encouraged not to use the word "safe", safely, safety or safer without qualification. A balanced reference to the product's tolerability is preferred. 3.4 Comparisons Comparisons must be made on a factual and fair basis and be capable of substantiation in accordance with the balance of medical evidence Comparisons must not mislead by distortion, by undue emphasis, or in any other way. Hanging comparatives - those that claim a product is better, stronger, or more widely prescribed - must not be used Where a claim of comparative efficacy or safety is made, it must not be based solely on a comparison of NZ approved Data Sheets, as those documents are based on different clinical databases and thus the data are not directly comparable. Comparative claims that relate to a specific parameter must be clearly identified as pertaining to that parameter and referenced as such Product comparisons should not be used in Direct to Consumer Advertising. (See also Principle 5.4). Page 17

18 3.4.5 The accepted level of statistical significance is p If comparative data that are not statistically significant are used, such data must comply with the following conditions: The lack of significance must be stated explicitly; it is insufficient to state only the p value; and The statement that the claim is not statistically significant needs to be linked to the original claim, made on the same page and within a reasonable proximity of the original claim in a manner that is not obscured by other material. The data must not be used to generalise or to indicate superiority or inferiority. 3.5 Data on File Promotional claims should not rely exclusively on data on file unless they are part of the approved registration package. 3.6 Disparaging References The products or services of other pharmaceutical companies and the clinical and scientific opinions of healthcare professionals must not be insulted or subject to unreasonable or unfair criticism either directly or by implication. Objective or scientific comment is acceptable. 3.7 Personal Communication Where the views of individual clinicians are used in promotional claims, they should be balanced, fair, and consistent with current scientific evidence. (See also Principle 3.12). 3.8 Quotations Whilst it is acceptable for a Healthcare Professional to express his/her personal view of a treatment regimen in an article or at a conference, once a company translates this view into a company promotional piece and proactively distributes the piece to HCPs, the company must accept responsibility for the content. It is the responsibility of the company to ensure that any promotional material is fully compliant with the provisions of the Code and does not conflict with the product Data Sheet It is permissible to include in promotional material directed at Healthcare Professionals reasonably brief abstracts or quotations from a published article by a member of the medical profession, and to include in such material a reference to the medical practitioner s name in a bibliography of published works. Quotations must not change or distort the original meaning and must reflect the meaning of the entire article and the author s current opinion Quotations relating to prescription products taken from unpublished public broadcasts, conferences or symposia must not be used in promotional material without the presenter s written permission (unless the content is subsequently published, and can thus be referenced to the published article). Care should also be taken to avoid ascribing unpublished claims or views relating to prescription products Page 18

19 to a presenter when such claims or views no longer represent, or may not represent, the current view of that person. 3.9 The word "new" should not be used to describe any product or presentation that has been generally available, or any therapeutic indication that has been generally promoted, for more than twelve (12) months in New Zealand Publication - Where a company finances or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble independent editorial matter but must be clearly identified as companysponsored promotional material Advertorials are medical advertisements as defined in the Medicines Act Advertorials or company commissioned articles must be identified as such in a type size of not less than 2mm as measured by the height of the font s lower case e The company that is responsible for the insertion of the advertorial or company commissioned article must be clearly identified at either the top or the bottom of the company commissioned article in a type size of not less than 1.5mm as measured by the height of the font s lower case e. NOTE: Where a company sponsors editorial space without any control over the content, the sponsoring contract should reflect the requirement for editorial independence. Only where a company can show that it had no control over the content of an editorial can the article be considered of a non-promotional nature. Any such articles should include the statement that "the views of the author are not necessarily those of the sponsor or publisher" Endorsements Advertisements and promotional material must not claim or imply endorsement by any government agency, professional body or independent agency unless there is prior consent, the endorsement is verifiable and the agency or body is named. Testimonials, where not prohibited by law, or this Code, should be valid, true, current, verifiable, typical and documented Government Agencies The Medicines Regulations 1984, regulation 7 states that advertisements are not to claim official approval. "No advertisement relating to any medicine, related product, or medical device shall contain a statement to the effect that an advisory or technical committee established under section 8 of the Medicines Act 1981, or any member of such a committee, or any officer in the service of the Government, has approved, or has refrained from disapproving, the advertisement or any of the claims or statements made in it." Similarly, Part A section 1.12 of the New Zealand Regulatory Guidelines for Medicines (Edition 6.9, August 2010, p. 11) indicates that consent is not to be used for promotional purposes. Specifically, it states, "Consent not to be used for Promotional Purposes - Ministerial consent for the distribution of a new or changed medicine, or Page 19

20 related product is not to be construed as an endorsement of any claim made for the product. No reference may be made to this consent in any label or advertising, promotional or other published material about the product." Pharmaceutical Schedule - Where reference is made to the prescribing of a preparation in terms of the Pharmaceutical Schedule, the phrase "freely prescribed on the Pharmaceutical Schedule" and similar misleading phrases must not be used. Companies must not state or imply to a doctor or a patient that a product which is not currently listed on the Pharmaceutical Schedule will be listed on the Pharmaceutical Schedule in the future or will attract any other form of Government subsidy In promotion of a product to healthcare professionals or to consumers (DTCA), no company shall intimate or imply endorsement by any appropriate professional body or patient advocacy group without prior consent. The consent must be given in writing and available upon request, and must be appropriately referenced in any advertisements Any advertisement or promotion to the general public (i.e., DTC Advertising) must not directly or by implication claim, indicate, or suggest that a medicine is or has been used, recommended, or endorsed by a healthcare professional (including the use of an actor portraying a healthcare professional) or by a celebrity If the name or testimonial of a healthcare professional is used in advertisements or promotional material to other healthcare professionals, other than by citing published references, their written approval must be obtained and available upon request. Care must always be taken to ensure that the representation of their views is balanced, fair, and up to date Electronic Media Promotion Medicines New Zealand supports the right of member companies to use the Internet as a means of providing accurate and scientifically reliable information on medicines in a responsible manner for the benefit of both patients and healthcare professionals. This section applies to any electronic or audiovisual media designed by companies to promote their products, including (but not limited to): the internet electronic mail (including and text messages) software programmes used by Medical Representatives during interchanges with healthcare professionals material for individual use by healthcare professionals or consumers material for demonstration purposes to an individual or group(s) of healthcare professionals advertisements in such programmes as prescribing and dispensing software All material in electronic media that promote prescription medicines, including websites originating in New Zealand, should comply with the sections of this Code relevant to the nature of the promotional material and target audience. Page 20

21 Unsolicited electronic mail ( ) transmissions are prohibited by law and must not be used for promotional purposes Information provided on the internet and intended only for use by healthcare professionals must be accessible only via a secure system that is designed to prevent access by members of the general public All electronic promotional material must contain, or be accompanied by, the information required for the intended audience and type of advertisement. e.g.: electronic promotional material that is accessible to the general public must comply with the requirements for DTCA within this Code. electronic promotional material that is only accessible to healthcare professionals must comply with the requirements for a Full or Short Advertisement, as appropriate Publicly accessible websites must contain a copy of the product s Consumer Medicine Information (CMI) or provide a direct link to the product s CMI on the Medsafe website Where references to other information sources or internet sites are made, companies must ensure that these other information sources or internet sites comply with this Code Where references or links to other information sources or internet sites are made, companies must take all reasonable steps to ensure that these sources are reputable and provide reliable educational material that will encourage appropriate prescribing, dispensing and use of medicines in New Zealand. Companies must also not knowingly advertise or link to websites that promote unapproved product(s), or unapproved uses of their product(s) Where links are provided to sites outside of New Zealand jurisdiction, website users should be made aware that they are being redirected to a site outside of New Zealand jurisdiction and that the information on the linked site may not be consistent with the New Zealand approved Data Sheet A list of substantiating references must be provided in electronic promotional material whenever a promotional claim is made When product-specific websites are accessible to the general public, they are deemed Direct To Consumer Advertising, must comply with the DTCA sections of this Code, and must provide on the website, or link directly to, the CMI of the product being promoted. The CMI is regarded as the consumer equivalent to a Data Sheet and should be written at a level that can be readily understood by members of the lay public. Page 21

22 Product related pages on company websites based in NZ must include a TAPS approval number (non-product content is the responsibility of the company and does not require TAPS review) Websites may also contain information about current research or clinical data that would help members of the general public understand how a prescription medicine works, its uses and/or compliance advice. All information provided to members of the general public about prescription medicines on New Zealand based websites must be in accord with the product s current New Zealand approved Data Sheet Websites accessible to the general public must state that any information provided on the website should be discussed with a healthcare professional, and does not replace a healthcare professional s advice Any offers promoted on a New Zealand originated website would generally be applicable only to New Zealand residents, as the laws of other countries may be different. It is prudent to advise overseas consumers of this point in a statement such as Note: This offer or information applies only to New Zealand residents. Different conditions may apply in other countries Competitions directed at consumers are prohibited Where websites solicit personal consumer information through orders, clubs and general newsletter follow-up this should be done in accordance with the Privacy Act Such websites should contain a statement similar to: Note: Your personal information will be kept confidential and not distributed to third parties. You have the right to inspect, change or delete this information Advertisements or information intended for distribution via any form of social media is considered Direct to Consumer Advertising, and must comply with the provisions of Section 5 of this Code Events/Programme Sponsorship Advertising Any product-related sponsorship advertisements directed at the public shall comply with the requirements for DTC Advertising within this Code Any product-related sponsorship advertisements directed solely at healthcare professionals shall comply with the requirements for advertisements to healthcare professionals. Page 22

23 4. Activities Directed at Healthcare Professionals 4.1 Advertisements to healthcare professionals All advertisements and promotional material should include a clear and prominent statement drawing the attention of the reader to any restriction or nonavailability of a medicine via the Pharmaceutical Schedule. The disclosure of this information must accurately reflect the approval and pharmaceutical schedule listing but may be a paraphrase or précis of that information Full advertisements A full advertisement is any advertisement that includes a therapeutic claim A full advertisement must contain the following within the body of the advertisement: (a) The brand name of the product. (b) The New Zealand Approved Name(s), usually INN, of the active ingredient(s). (c) The quantities of the active ingredients in the medicine. (d) The name of the sponsor and the locality of the registered office. (e) The medicine classification. (f) The approved indication(s) of relevance to the advertisement. (g) Contra-indications to the use of the product.* (h) Common and serious adverse events associated with the use of the product.* (i) Appropriate precautions for the use of the product.* (j) A clear statement regarding the funding status of the product or any restrictions to the Pharmaceutical Schedule listing. Examples include X is an unfunded medicine a prescription charge will apply X is a partially funded medicine a prescription charge will apply X is a funded medicine Restrictions apply (The source of any funding restrictions, e.g. the Pharmaceutical Schedule, should be properly noted in the references of the promotional piece). (k) A clear statement directing the prescriber to review the Data Sheet before prescribing the medicine. (l) Reference to where the Data Sheet is immediately accessible. (It remains the company s responsibility to ensure that the Data Sheet is in fact immediately accessible, e.g. on the Medsafe website or similar source). *As a minimum, the most important information in these categories should be included Care should be taken to ensure that the covers of promotional items also comply with the requirements for promotional materials. Page 23

24 4.1.3 Short advertisement Short advertisements are prohibited from use in Direct to Consumer Advertising A short advertisement is designed to remind a prescriber of a product s existence but must not contain promotional claims A short advertisement must contain: a) The brand name of the product. b) The New Zealand Approved Name(s), usually INN, of the active ingredient(s). c) The name of the sponsor and the locality of the registered office. d) A clear statement directing the prescriber to review the Data Sheet before prescribing the medicine. e) Reference to where the Data Sheet is immediately accessible. (It remains the company s responsibility to ensure that the Data Sheet is in fact immediately accessible, e.g. on the Medsafe website or similar source). A short advertisement may also contain: f) Words describing the therapeutic class, or approved uses (i.e., indication(s)) for the product, but without the use of promotional phrases. g) A statement of available dosage forms. h) Graphics of a non-promotional nature. i) Details of the reimbursement status of a medicine. j) The medicine classification. k) A statement that further information is available from the company. l) The website or other contact details of the company Brand Name Reminder Items An individual Brand Name Reminder Item should only be of token value, should not bring discredit to the industry and should be chosen on the basis that the item is clearly a Brand Name Reminder and not any other form of promotional material. The nature of any Brand Name Reminder Item or its packaging must not have the capacity to be confused with a therapeutic product Brand Name Reminder Items must have some relevance to healthcare practice. Items that are more likely to be regarded as being for use in the home, or for recreational activities, are prohibited Brand Name Reminder Items should be of token value, i.e., not likely to be greater than NZ$20.00 per item (excl GST) Brand Name Reminder Items must: a) be inscribed with the Brand and approved name (usually the INN) and company name or logo. Page 24

25 b) not contain any promotional claims, including promotional tag lines and/or statements. c) be directed only to healthcare professionals. d) not contain any other information, e.g. therapeutic class, approved use(s). 4.2 Medical Literature and Reprints This section applies to medical literature, reprints of journal articles and proceedings of educational events distributed via print, audio visual or electronic storage media, websites or podcasts The general interpretation and conclusions of any reprints of journal articles, proceedings of educational events or summaries of literature used in promotion must be consistent with the Data Sheet Quotations from medical literature or from personal communications must accurately reflect the meaning of the author and statistical significance of the study. No part of the reprint or article should be specifically highlighted to draw the attention of the healthcare professional Healthcare professionals may request literature on subjects not covered by the Data Sheet, such as unapproved indications. While it is not acceptable to routinely disseminate such literature where unsolicited, it is acceptable to provide such information on individual request, provided that the literature or accompanying communication clearly identifies that it refers to a product or indication not approved in New Zealand. If the product is approved in New Zealand, it must be accompanied by the New Zealand Data Sheet, or the response must direct the HCP to the Data Sheet available at as appropriate. Information provided on unapproved products or indications in response to an unsolicited request by an HCP must be balanced and not promotional and should be distributed by the Medical Department. Medical representatives must not promote the use of unapproved indications or products to healthcare professionals Reprints themselves do not need to be accompanied by the Data Sheet, but any accompanying material (including covering letters) or presentation made that incorporates promotional claims must comply with the requirements of this Code (see also 4.1.2). 4.3 Conference Reports Any reports from educational events held or sponsored by a company must be a balanced, true and accurate reflection of that meeting It is recommended that if a company sponsors an independently edited supplement, this should be stated clearly in the supplement. If a company does sponsor the reporting of a congress or symposium, this activity must comply with the requirements of the Code. Page 25

26 NOTE: Waivers or disclaimers will not abrogate a company s responsibility if the material includes reference to off-label use of a product In addition to those reports prepared by a company, this section applies to reports prepared by individuals on behalf of companies 4.4 Reference Manual Advertising Advertisements in reference manuals in general should comply with the Code as above. In the event that the reference manual does not provide the Data Sheet, direction must be given in the body of the advertisement as to where this information can be obtained, e.g., or Please contact the company for the Data Sheet The MIMS New Ethicals Catalogue and the electronic MIMS are examples of reference manuals of use in New Zealand. 4.5 Mailings (including Electronic Mail) Mailings must comply will all relevant provisions of this Code Mailings in which promotional claims are made must comply with the requirements of this Code (see also and 4.1.3) Mailings (should only be sent to those categories of healthcare professionals that have a need for, or interest in, the particular information. (See for restrictions with electronic mail) Mailing lists should be kept up-to-date Requests by healthcare professionals to be removed from promotional mailing lists must be complied with promptly and no name restored except at specific request or with written permission Exposed mailings to healthcare professionals including postcards, envelopes or wrappers must not carry matter which might be regarded as promotion to the general public or which could be considered unsuitable for public view The display of a product s brand name and logotype, NZ Approved Name and INN name alone on mailings directed towards healthcare professionals is not considered as promotion to the general public in this context. Within this context however, taglines are not allowed Statements on envelopes implying urgent attention should be restricted to matters relating to product recalls or important safety information Envelopes should not be used for dispatch of promotional material if they bear words implying that the contents are non-promotional. Page 26

27 Any accompanying material sent with a mailing must comply with the requirements of this Code as a stand-alone item. 4.6 Professional Trade Displays Professional Trade Displays must be directed only to healthcare professionals A Professional Trade Display must include the name of the sponsoring company Companies must ensure that any overseas affiliates sponsoring or involved in such meetings are made aware of and comply with the Code All promotional material used at a Professional Trade Display must comply with the requirements of this Code Banner advertisements exhibited at Professional Trade Displays must: a) have the brand name and New Zealand Approved Name(s), [usually the INN, of the active ingredient(s)], and the name or logo of the sponsor and the locality of the registered office; b) have a TAPS or Delegated Authority approval number; c) have the respective Data Sheet available at the Trade Display; d) not contain any promotional claims, including promotional tag lines and/or statements (except as in 'g' below); e) be directed only to healthcare professionals. Banner advertisements exhibited at Professional Trade Displays may also: e) have a brief statement of the approved uses (indication(s)). f) include the company address. g) include additional information so as to comply with the requirements of a Full Advertisement or a Short Advertisement as outlined in this Code The Data Sheet for products being promoted must be available from the Professional Trade Display stand Sample/Starter Packs must not be made available for collection from Professional Trade Display stands Sample/Starter Packs or products not approved for marketing in NZ must not be provided Competitions that are held as part of a Professional Trade Display must be consistent with the requirements of this Code To encourage healthcare professionals to attend a Professional Trade Display a Company may offer Brand Name Reminder Items. Page 27

28 Gifts, cash payments and/or donations to charities or societies must not be offered to healthcare professionals to visit Professional Trade Display stands Any activities of a company in relation to its Professional Trade Display must be able to successfully withstand public and professional scrutiny, and conform to professional and community standards of ethics and good taste. 4.7 Interactions and Relationships with Healthcare Professionals The primary objective for any interaction with healthcare professionals is to benefit patients by increasing medical knowledge and enhancing the quality use of medicines in New Zealand Relationships with Healthcare Professionals must be able to withstand public and professional scrutiny and conform to professional and community standards of ethics and good taste. No financial or material benefits should be provided on condition that the Healthcare Professional recommends or prescribes a prescription medicine Companies may choose to support, initiate or become involved in activities with healthcare professionals. Such involvement either by financial or other means must be able to successfully withstand public and professional scrutiny, and conform to professional and community standards of ethics and of good taste Gifts to Healthcare Professionals must not be in cash Payment for access to healthcare professionals is prohibited. 4.8 Company Educational Events Informational presentations and discussions by industry representatives and others speaking on behalf of a company (including, for example, company organised medical education programmes or symposia) provide valuable scientific and educational benefits. In connection with such presentations or discussions, occasional meals may be offered so long as they: (a) appropriately reflect the professional standing of the audience and the level of hospitality and expenditure are not out of proportion to the occasion; (b) are clearly secondary to the educational purpose of the meeting; and (c) occur in a venue and manner conducive to informational communication and scientific or educational learning Invitation of a Healthcare Professional s partner or other guests is prohibited unless the partner or guest is also a Healthcare Professional and would have been invited in their own right Offering "take-out" meals or meals to be eaten without a company representative being present (such as "dine & dash" programmes) are prohibited. Page 28