APMI CODE OF PRACTICE ON ADVERTISING OF MEDICINAL PRODUCTS ISSUE 1

Transcription

1 APMI CODE OF PRACTICE ON ADVERTISING OF MEDICINAL PRODUCTS ISSUE 1 August 2010

2 1. Introduction Scope Definitions General rules of advertising of medicinal products Advertising to the general public Advertising to persons qualified to prescribe or supply Conformance with the Code

3 1. Introduction This Code of Practice on Advertising of Medicinal Products has been prepared by the Association of Pharmaceutical Manufacturer s of Ireland (APMI) in consultation with the Department of Health and Children and The Irish Medicines Board. The scope of this Code is to ensure that the advertising of medicinal products aimed at both healthcare professionals and the general public is carried out within a robust framework, and to ensure that all pharmaceutical companies (in particular those members of APMI) operate in a responsible, ethical and professional manner. The advertising of medicinal products for human use within the European Union is governed by Directive 2001/83/EC (as amended by Directive 2004/27/EC). In Ireland, Titles VIII and VIIIa of Directive 2001/83/EC (as amended by Directive 2004/27/EC) are implemented by the Advertising Regulations, [The Medicinal Products (Control of Advertising) Regulations, 2007 (S.I. No. 541 of 2007)] which came into operation on the 23 rd of July These Regulations should be used in conjunction with this Code for the review and approval of advertising materials for medicinal products. However, the legislative provisions governing the advertising of medicinal products, (S.I. No. 541 of 2007) will take precedence over this Code of Practice on Advertising of Medicinal Products should conflict between the two arise. The nature of the endorsement that can be given by the Minister will be in respect of the sections of the Code that are directly derived (verbatim) from the The Medicinal Products (Control of Advertising) Regulations, 2007 (S.I. No. 541 of 2007). 2

4 2. Scope 2.1. This Code applies to any advertisement relating to a medicinal product where such product is the subject of a marketing authorisation or certificate of traditional-use registration in Ireland This Code is intended to assist Marketing Authorisation Holders in the self-regulation of advertising materials This Code does not apply to the labelling of medicinal products and the accompanying package leaflets, (which are in compliance with Regulation 16 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007); correspondence which may be accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product; factual informative announcements and reference material relating, for example, to pack changes, adverse reaction warnings as part of general drug precautions, trade catalogues and price lists provided they include no product claims; books, journals, periodicals and other publications that are imported into the State and which contain advertising which is not intended for or directed at persons resident in the State; information relating to human health or diseases, provided there is no reference, even indirect, to medicinal products. e.g. patient information or disease awareness campaigns carried out by pharmaceutical companies themselves or in conjunction with patients associations; any advertisement relating to a registered homeopathic medicinal product; herbal medicinal products which had already been on the market prior to the coming in to place of the Advertising Regulations (until 30 th April 2011); products which may be used as an accessory to medicinal products (e.g. saline solutions) and are not the subject of a marketing authorisation, provided there is no mention of a medicinal product; foodstuffs or food supplements which are not the subject of a marketing authorisation or certificate of traditional-use registration. 3

5 3. Definitions In this Code the following definitions apply: advertising, in relation to a medicinal product, includes any form of advertising whether in a publication, or by display of a notice or point-of-sale material, or by means of a letter, press release or other document, or by the exhibition of a photograph or by way of a radio or television broadcast or via the internet. It also includes any form of door to door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products and including in particular- the advertising of medicinal products to the general public; the advertising of medicinal products to persons qualified to prescribe or supply them; visits by medical sales representatives to persons qualified to prescribe medicinal products; the supply of samples of medicinal products; the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind; the sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products; the sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith; Board means the Irish Medicines Board established by Section 3 of the Irish Medicines Board Act 1995; common name in relation to a medicinal product means the international nonproprietary name, or, if one does not exist, the usual common name; certificate of traditional-use registration means a certificate of traditional-use registration which is for the time being in force and which has been granted by the Board under the Medicinal Products (Control of Placing on the Market) regulations 2007 in respect of a traditional herbal medicinal product; healthcare professional means a person of any of the following classes: registered medical practitioners, registered dentists, registered pharmacists, registered nurses; herbal medicinal product means any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations; 4

6 marketing authorisation means an authorisation which is for the time being in force and which has been granted by the Board in accordance with the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007) and includes a product authorisation, a parallel import license, an authorisation granted by the Commission under Regulation (EEC) No. 2309/93 or Regulation (EC) No 726/2004 and an authorisation granted by the Board in accordance with Article 126a of the 2001 Directive; medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means. 'misleading advertising' means any advertising which in any way, including its presentation, deceives or is likely to deceive the persons to whom it is addressed or whom it reaches and which, by reason of its deceptive nature, is likely to affect their economic behaviour or which, for those reasons, injures or is likely to injure a competitor; promotional aid means a non-monetary gift, that is inexpensive, relevant to the practice of medicine or pharmacy, and is made for a promotional purpose by a commercially interested party; summary of product characteristics means the information required to accompany any application for a marketing authorisation or certificate of traditional-use registration by virtue of article 11 of the 2001 Directive. 5

7 4. General rules of advertising of medicinal products 4.1. A medicinal product must not be promoted prior to receipt of the marketing authorisation or certificate of traditional-use registration authorising its sale All product promotion must comply with the terms of the marketing authorisation or certificate of traditional-use registration An advertisement in respect of a medicinal product must not be issued unless all parts of the advertisement comply with the particulars set out in the summary of product characteristics for the product the advertisement encourages the rational use of the medicinal product by presenting it objectively and without exaggerating its properties the advertisement is not misleading the advertisement meets fully the requirements of the relevant legislation Advertising must be legal, decent, honest and truthful Advertising materials must be prepared with a sense of responsibility to consumers and society and must not bring discredit upon or reduce confidence in the pharmaceutical industry Advertising materials must respect the principles of fair competition Advertising material must not exploit the credulity, inexperience or lack of knowledge of the target audience An advertisement must not persuade or tend to persuade towards the unnecessary use of the product All information in an advertisement must be capable of substantiation. Claims must not be exaggerated and the use of superlatives should be avoided. The use of statistics and technical data must be accurate and must not be presented in such a way as to exaggerate the validity of a claim Wording which implies superior or superlative status such as number one, leading, largest etc. must be capable of substantiation with market share data or similar proof The word new must not be used to describe a medicinal product which has been available in Ireland for more than 12 months. 6

8 The word safe must not be used without qualification. Medicinal products must not be promoted as being free from side effects, toxic hazards or risk of addiction Comparisons to other products must be fair and capable of substantiation. Brand names of products of other companies must not be used without the prior consent of the other company. An advertisement must not so closely resemble another as to be likely to mislead or cause confusion The design and presentation of advertising materials must allow them to be clearly understood. Where footnotes or small print sections are used, they must be of sufficient size and prominence and be easily legible Advertising materials must not claim or imply an endorsement where none exists. Advertisers who use testimonials must be able to provide relevant supporting documentation and they must hold signed and dated proof for any testimonials they use. Testimonials by persons named or depicted in an advertisement must only be used with the prior permission of those persons and only where such permission still holds. Endorsements by fictitious or historical characters must not be presented as though they were genuine testimonials even in the presence of a disclaimer. Consideration must also be given to Clause of this Code regarding the use of endorsements/ testimonials Advertising materials must not cause fear or distress without good reason. In such cases the fear aroused should not be disproportionate to the risk Advertising materials must not contain a statement that the marketing of the product has been approved by the Irish Medicines Board, European Medicines Agency or other organisations Advertising materials may only refer to company s websites or other independent websites where the website is also in compliance with the applicable legislation and this Code. 7

9 5. Advertising to the general public This section applies only to advertisements that are directed wholly or mainly at members of the general public The advertising and promotion of prescription only medicines to the general public is prohibited (not applicable to any advertisement that forms part of a vaccination campaign relating to a vaccine or serum provided that such a campaign has been approved by the Minister) Advertising in respect of a controlled drug (as defined in Section 2 of the Misuse of Drugs Act [No. 12 of 1977]) is prohibited. This should be borne in mind when preparing advertising for consumer healthcare medicines, some of which may contain controlled substances, e.g. codeine, dextromethorphan Consideration should be given to the Medicinal Products (Control of Paracetamol) Regulations [S.I. No. 150 of 2001] in conjunction with the Medicinal Products (Prescription and Control of Supply) Regulations [S.I. No. 540 of 2003] when preparing advertising materials for medicinal products containing paracetamol An advertisement aimed at the general public must be set out in such a way that it is clear that the message is an advertisement and that the product is a medicinal product; 5.5. Advertisments intended for members of the general public must not contain material which: gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering or by suggesting a treatment by mail (post, telephone, or any other electronic means of communication); suggests that the effects of a product are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to those of another treatment or medicinal product; suggests that the health of a subject can be enhanced by taking a medicinal product; suggests that the health of the subject could be affected by not taking the medicinal product (not applicable to any advertisement that forms part of a vaccination campaign relating to a vaccine or serum provided that such a campaign has been approved by the Minister); is directed exclusively or principally at children; 8

10 refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing, but who, because of their celebrity status, could encourage the consumption of medicinal products; suggests that the medicinal product is a foodstuff, cosmetic or other consumer product; suggests that the safety or efficacy of a product is due to the fact that it is natural; might, by description or detailed representation of a case history, lead to erroneous self diagnosis; refers, in improper, alarming or misleading terms to claims of recovery; uses, in improper alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or the action of a medicinal product on the human body or parts thereof; is intended to influence consumers in ways of which they are not consciously aware. Full advertisement 5.6. An advertisement aimed at the general public must contain the following minimum information: the name of the medicinal product; the common name of the medicinal product where there is only one active ingredient. Where there is more than one active ingredient, it is not necessary to list the common names, however, inclusion of all of the common names is not considered a breach of the Code; the information necessary for the correct use of the medicinal product as per the package leaflet or label. An invitation to read the label or leaflet as appropriate may be considered sufficient to fulfil this requirement where the method of administration is obvious; a warning to read carefully the instructions on the package leaflet or outer label as appropriate (in the case of an audio or visual promotion there must be an overprint or an audible statement which recommends that the consumer reads the instructions carefully); where the product is a traditional herbal medicinal product, the following statement Traditional herbal medicinal product for use in [one or more therapeutic indications for the product] exclusively based on long standing use. Reminder advertisement 5.7. An exemption from Clause 5.6 may be appropriate where an advertisement is intended as a reminder and consists solely of: the name of the product, its international non-proprietary name, where such exists, and/or the trademark 9

11 advice to read carefully the instructions on the package leaflet or on the label as appropriate the company name or trading style (no contact details). Inclusion of the company name is not an absolute requirement and may be included at the discretion of the company Sale or supply of any medicinal product for promotional purposes to members of the general public is prohibited. This applies to marketing authorisation or certificate of traditional-use registration holders or any person acting on their behalf, and persons who in the course of their business manufacture medicinal products or sell medicinal products by wholesale or any person acting on their behalf A company must not promote to the general public or be associated with any prize competition or other scheme which is intended to encourage the unnecessary use of a medicinal product. 10

12 6. Advertising to persons qualified to prescribe or supply This section applies only to advertisements that are directed wholly or mainly at persons qualified to prescribe or supply medicinal products. Such advertisements may be categorised as follows: Full advertisements (where the purpose is to provide sufficient information on which to reach a decision on prescribing or dispensing a medicinal product) Abbreviated advertisements (where the purpose is to remind a person qualified to prescribe or supply of the availability of a medicinal product) Promotional aids 6.1. Form and content of a full advertisement A full advertisement aimed at persons qualified to prescribe or supply must contain the following: essential information compatible with the summary of product characteristics. It is recommended to create an abbreviated prescribing information sheet (API) using the current version of the summary of product characteristics for the medicinal product. The API must include a date of preparation or date of last revision; the name of the product, and a list of the active ingredients using the common name placed immediately adjacent to the most prominent display of the name of the product. Immediately adjacent to means immediately before, immediately after, immediately above, or immediately below; the classification for the sale or supply of the product. i.e. medicinal product subject to medical prescription, retail sale through pharmacies only or supply through general sales ; one or more of the indications for the use of the product compatible with the terms of the marketing authorisation or certificate of traditional-use registration; a clear statement of the entries in the summary of product characteristics relating to adverse reactions, precautions, and relevant contra-indications; a clear statement of the entries in the summary of product characteristics relating to the dosage and method of use relevant to the indications shown. The method of administration must be given if this is not obvious; the name and address of the holder of the marketing authorisation or certificate of traditional-use registration, or the business name and address of the part of the business responsible for placing the product on the market; 11

13 the marketing authorisation or certificate of traditional-use registration number of the medicinal product; where the product is a traditional herbal medicinal product, the following statement Traditional herbal medicinal product for use in [one or more therapeutic indications for the product] exclusively based on long standing use ; the date on which the above particulars were generated or last updated Form and content of an abbreviated advertisement An abbreviated advertisement aimed at persons qualified to prescribe or supply must contain the following: the name of the product, its international non-proprietary name(s) where such exists, and/or the trademark; the classification for the sale or supply of the product. i.e. medicinal product subject to medical prescription, retail sale through pharmacies only or supply through general sales ; the name and address of the holder of the marketing authorisation or certificate of traditional-use registration, or the business name and address of the part of the business responsible for placing the product on the market; a statement which clearly indicates that additional information is available on request or in the summary of product characteristics relating to the product; where the product is a traditional herbal medicinal product, the following statement Traditional herbal medicinal product for use in [one or more therapeutic indications for the product] exclusively based on long standing use ; the date on which the above particulars were generated or last updated Promotional aids The conditions set out in Section 6.1 and 6.2 above are not applicable to an advertisement relating to a medicinal product which is on a promotional aid if; the advertisement consists solely of the name of the product, its international non-proprietary name and/or the trademark*; the advertisement in intended exclusively as a reminder; the promotional aid is intended for supply only to persons qualified to prescribe or supply medicinal products. 12

14 * the company name or trading style may appear along with the name of the product, however company contact details are not permitted Where promotional aids fall under the definition of a medical device they must bear the appropriate CE mark in accordance with the current Medical Device Directives Written material accompanying promotions Any written material sent to a healthcare professional as part of a promotion of a medicinal product must comply with the requirements of either Clause 6.1 or 6.2 above as appropriate Any information provided must be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his/her own opinion of the therapeutic value of the medicinal product Such written material must not include any quotations, references or tables or other illustrative matter from a medical journal or other scientific work unless it is accurately reproduced and the precise sources of the information are indicated Each item within a promotional pack sent to a healthcare professional should be treated as an independent piece of advertising Medical Sales Representatives A medical sales representative who promotes medicinal products to persons qualified to prescribe or supply such products must, during each visit, give to the healthcare professional or have available for them a copy of the summary of product characteristics for each product that he/she promotes A medical sales representative must report to the scientific service, established by the marketing authorisation holder, any information about the use of the products he/she promotes, with particular reference to any adverse reactions reported by healthcare professionals in the course of their visits. 13

15 6.6. Inducements and Hospitality In the course of promoting medicinal products, it is prohibited to promise or offer the following; any gift, financial advantage or benefit in kind unless it is inexpensive and relevant to the practice of medicine or pharmacy Where inexpensive gifts are provided to healthcare professionals the requirements of Clause should be borne in mind The prohibition of the giving of gifts/financial advantage in the course of medicinal product promotion does not preclude companies from providing support in the form of educational or research grants or sponsorship of equipment provided such grants or sponsorship are given to an institution and not directly to a healthcare professional. Such support must not be linked in any way with product promotion Hospitality may be offered at sales promotion events /professional and scientific events provided such hospitality is reasonable in level is strictly limited to the main purpose or scientific objective of the event, and is not extended to persons other than healthcare professionals The provisions outlined in will not prejudice the negotiation of prices, margins and discounts in the ordinary course of business provided such prices, margins and discounts are incorporated in the sales invoice as a consequence of such negotiation Free Medical Samples A free sample of a medicinal product must only be supplied to a healthcare professional qualified to prescribe such product and only where the following conditions are satisfied: the sample is provided on an exceptional basis only and for the purpose of acquiring experience in dealing with such a product; the number of such samples of each product that may be supplied to any one recipient in any one year shall be limited and in any case shall not exceed six in number. The provision, to a prescriber, of up to six samples per annum 14

16 of different strengths of the same product is permitted. The limit of six applies to each marketing authorisation the supply of any such sample is made only in response to a written request, signed and dated, by the recipient; the supplier of such samples maintains an adequate system of control and accountability; each such sample is no larger than the smallest presentation of the product on the market; each such sample is marked "free medical sample - not for sale" or words to the like effect; each such sample is accompanied by a copy of the summary of product characteristics for each such product It is not permitted to supply free medical samples of the following medicinal products: a product which is a controlled drug under Section 2 of the Misuse of Drugs Act 1977; antidepressants; hypnotics; sedatives; tranquillisers Distribution of promotional material to persons qualified to prescribe or supply Promotional material must only be distributed to healthcare professionals where it is reasonable to assume they would have an interest in the subject matter Excessive distribution of promotional material is considered inappropriate Mailing lists must be kept up-to-date and any requests from a healthcare professional for removal from a mailing list must be complied with Consideration should be given to exposed mailings, envelopes or wrappers used to distribute promotional material to healthcare professionals. Such materials must not carry any details which could be regarded as inappropriate advertising to the general public (refer to Section 5) The use of faxes, text messages, s and other electronic communications for promotional purposes is unacceptable without the prior consent of the recipient. 15

17 7. Conformance with the Code 7.1. Marketing authorisation holders and holders of certificates of traditional-use registration have primary responsibility for ensuring that their advertising is in conformance with all relevant legislation Marketing authorisation holders and holders of certificates of traditional-use registration must establish a Scientific Service responsible for information about its medicinal products The Scientific Service must include appropriately qualified personnel and will be responsible for: approving all advertising material before use. A member of the Scientific Service must certify that they have examined the final version of all such material and that it is in accordance with the Code and applicable legislation; maintaining a sample of all advertising materials with records of those to whom it was distributed, the method and date of first distribution. Advertising materials should be retained for a period of three years from their cessation of use; provide, on request from the IMB, details of any advertisement or proposed advertisement generated by the marketing authorisation holder ensuring that, any decision taken by the IMB in relation to an advertisement relating to a medicinal product is immediately complied with compiling and collating all information, whether received from medical sales representatives or from any other source, relating to the medicinal products promoted by the marketing authorisation holder; ensuring medical sales representatives are given adequate training and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about the products they promote; ensuring medical sales representatives have available summaries of product characteristics for each medicinal product that he or she presents to health professionals; ensuring that medical sales representatives transmit information about the use of the medicinal products that he or she advertises, in particular any adverse reactions reported by healthcare professionals. 16