CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY 2015

Transcription

1 CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY 2015

2 CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY 2015 together with the PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY Constitution and Procedure This edition of the Code of Practice comes into operation on 1 January During the period 1 January 2015 to 30 Apri 2015, no materia or activity wi be regarded as being in breach of the Code if it fais to compy with its provisions ony because of requirements which this edition of the Code newy introduces.

3 THE PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY The Prescription Medicines Code of Practice Authority was estabished by the Association of the British Pharmaceutica Industry in 1993 to operate the Code of Practice for the Pharmaceutica Industry independenty of the Association itsef. Compaints shoud be submitted to the Director of the Prescription Medicines Code of Practice Authority, 7th Foor, Southside, 105 Victoria Street, London SW1E 6QT, teephone , facsimie , emai Compaints made under the Code are considered by the Code of Practice Pane and, where required, by the Code of Practice Appea Board. Reports on cases are pubished by the Authority and are avaiabe on request and on the Authority s website Copyright 2015 Association of the British Pharmaceutica Industry.

4 CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY 2015 C O N T E N T S CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY Page Introduction 4 1 Scope of Code and Definition of Certain Terms 6 2 Discredit to, and Reduction of Confidence in, the Industry 9 3 Marketing Authorization 9 4 Prescribing Information and Other Obigatory Information 10 5 Abbreviated Advertisements 12 6 Journa Advertising 14 7 Information, Caims and Comparisons 14 8 Disparaging References 16 9 High Standards, Format, Suitabiity and Causing Offence, Sponsorship Provision of Reprints and the Use of Quotations Distribution of Materia Disguised Promotion Cinica Trias and Non - Interventiona Studies of Marketed Medicines Certification Representatives Training Provision of Medicines and Sampes Prohibition on Inducements and Inappropriate Payments, the Provision of Items for Patients, Heath Professionas and Other Reevant Decision Makers, Agreements to Benefit Patients such as Outcome Agreements and Patient Access Schemes Medica and Educationa Goods and Services Joint Working Reationships and Contracts with Certain Organisations Meetings, Hospitaity and Sponsorship The Use of Consutants Transfers of Vaue to Heath professionas and Heathcare Organisations Scientific Services Reations with the Pubic and the Media Reationships with Patient Organisations The Internet Compiance with Undertakings 40 PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY CONSTITUTION AND PROCEDURE 41 GUIDELINES ON COMPANY PROCEDURES RELATING TO THE CODE OF PRACTICE 53 LIST OF LEGISLATION, OTHER CODES & GUIDELINES 60 INDEX 61 In the Code of Practice, guidance on the interpretation of the Code appears as suppementary information to the text against a pae bue background. CODE OF PRACTICE 3

5 CODE OF PRACTICE for the PHARMACEUTICAL INDUSTRY INTRODUCTION Promoting Appropriate Use of Medicines The pharmaceutica industry in the United Kingdom is committed to benefiting patients by operating in a professiona, ethica and transparent manner to ensure the appropriate use of medicines and support the provision of high quaity heathcare. This commitment appies to a with whom the industry interacts. To demonstrate this commitment over 50 years ago, in October 1958, the Association of the British Pharmaceutica Industry (ABPI), which represents the UK industry, decided that certain activities shoud be covered in detai and thus agreed the first ABPI Code of Practice. The Code covers the promotion of medicines for prescribing to both heath professionas and other reevant decision makers. It aso incudes requirements for interactions with heath professionas. In addition it sets standards for the provision of information about prescription ony medicines to the pubic and patients, incuding patient organisations. In addition to the Code there is extensive UK and European aw reating to the promotion of medicines. The Code refects and extends beyond the reevant UK aw. The aim of the Code is to ensure that the promotion of medicines to heath professionas and other reevant decision makers is carried out within a robust framework to support high quaity patient care. As we as covering promotiona materia, it contros sampes, meetings, promotiona aids, the provision of medica and educationa goods and services, outcome or risk sharing agreements, patient access schemes, joint working between the pharmaceutica industry and the NHS, the conduct of non-interventiona studies, the use of heath professionas and other reevant decision makers as consutants and transfers of vaue to heath professionas, other reevant decision makers and heathcare organisations. The Code aso sets standards reating to the provision of information to patients and the pubic as we as reationships with patient groups. The industry considers that provided the requirements of the Code are met, working with patients and patient organisations can bring significant pubic heath benefits. These requirements aso appy to working with a user groups, such as disabiity associations, reative and carer associations and consumer associations. In summary, companies must ensure that their materias are appropriate, factua, fair and capabe of substantiation and that a other activities are appropriate and reasonabe. Ensuring High Standards The detaied provisions in the Code are to ensure that pharmaceutica companies operate in a responsibe, ethica and professiona manner. Whist the industry has a egitimate right to promote medicines to heath professionas, the Code recognises and seeks to achieve a baance between the needs of patients, heath professionas and the pubic, bearing in mind the poitica and socia environment within which the industry operates and the statutory contros governing medicines. The avaiabiity of accurate up-to-date information is vita to the appropriate use of medicines. Pharmaceutica companies must ensure that enquiries about their medicines are answered appropriatey in a timey manner. Strong support is given to the Code by the industry with a companies devoting considerabe resources to ensure that their activities compy with it. Any compaint made against a company under the Code is regarded as a serious matter both by that company and by the industry as a whoe. Sanctions are appied against a company rued in breach of the Code. Companies must ensure that a reevant personne are appropriatey trained in the requirements of the Code and must have robust operating procedures under which a materias and activities covered by the Code are reviewed to ensure compiance both with the Code and with the appropriate ega requirements. The Code incorporates the principes set out in: the Internationa Federation of Pharmaceutica Manufacturers and Associations (IFPMA) Code of Practice the European Federation of Pharmaceutica Industries and Associations (EFPIA) Code on the Promotion of Prescription-Ony Medicines to, and Interactions with, Heathcare Professionas the EFPIA Code of Practice on Reationships between the Pharmaceutica Industry and Patient Organisations the EFPIA Code on Discosure of Transfers of Vaue from Pharmacutica Companies to Heathcare Professionas and Heathcare Organisations the Word Heath Organisation s Ethica Criteria for Medicina Drug Promotion Directive 2001/83/EC on the Community Code reating to medicina products for human use, as amended by Directive 2004/27/EC The Human Medicines Reguations 2012 (2012 No.1916), as amended. The Code covers the industry s activities ony. However those interacting with industry as individuas or organisations aso have a responsibiity to ensure that their interactions compy with reevant ega requirements and are asked to foow the Code where reevant and not make requests that are not in accordance with the Code. Most of those interacting with the industry, other than patients, are covered by a seection of professiona codes and guidance. For exampe, the Genera Medica Counci Good Medica Practice, the Genera Pharmaceutica Counci Standards of conduct, ethics and performance and the Nursing & Midwifery Counci Standards of conduct, performance and ethics for nurses and midwives. Patient organisations are ikey to be covered by Charity 4 CODE OF PRACTICE

6 Commission rues as we as their own codes. The pharmaceutica industry takes note of a reevant codes and guidance as we as the ABPI Code. Transparency The industry recognises that transparency is an important means of buiding and maintaining confidence. The operation of the Code, incuding the compaints procedure, is a demonstration of the industry s commitment to transparency as are the requirement to decare pharmaceutica company invovement in activities and materias and the pubication of detaied reports of cases considered under the Code. The industry s goba agreement to discose certain cinica tria data is another exampe of the industry s commitment to transparency. Companies aso have to pubish the summary detais and resuts of non-interventiona studies as we as the monetary vaue of certain support to patient organisations. Other transparency changes, effective in 2012 and 2013, incuded discosure of the tota amount of fees paid to consutants for certain services and the tota amounts paid to sponsor attendance at meetings organised by third parties. As set out in the 2014 Code, in 2015 and 2016 transparency wi be extended in reation to fees and sponsorship provided to heath professionas and heathcare organisations, incuding naming the recipients in many instances. Sanctions In each case where a breach of the Code is rued, the company concerned must give an undertaking that the practice in question has ceased forthwith and that a possibe steps have been taken to avoid a simiar breach in the future. An undertaking must be accompanied by detais of the action taken to impement the ruing. At the concusion of a case a detaied case report is pubished. Additiona sanctions are imposed in serious cases. These can incude: the audit of a company s procedures to compy with the Code, foowed by the possibiity of a requirement for the pre-vetting of future materia recovery of materia from those to whom it has been given the issue of a corrective statement a pubic reprimand advertising in the medica, pharmaceutica and nursing press of brief detais of cases in which companies were rued in breach of Cause 2 of the Code, were required to issue a corrective statement or were the subject of a pubic reprimand suspension or expusion from the ABPI. Monitoring of Activities and Guidance The Prescription Medicines Code of Practice Authority (PMCPA) arranges for advertising and meetings to be reguary monitored. The PMCPA aso provides informa guidance about the Code and its operation. Promoting Heath The commitment of Britain s pharmaceutica industry to providing high quaity effective medicines brings major benefits to both the nation s heath and economy. The pharmaceutica sector makes a significant contribution to the UK economy and generates an annua trade surpus of 2.8 biion. One sixth of the word s most popuar prescription medicines were deveoped in the UK. Investment into researching and deveoping new products in the UK is now running at over 4.2 biion a year and each new medicine takes over tweve years to deveop before it is authorized for use, with no guarantee of commercia success. The Association of the British Pharmaceutica Industry and its Code of Practice The Association of the British Pharmaceutica Industry (ABPI) is the trade association representing manufacturers of prescription medicines. It represents companies which suppy 90 per cent of a medicines used by the Nationa Heath Service, and are researching and deveoping 90 per cent of the current medicines pipeine. The Code has been reguary revised since its inception in 1958 and is drawn up in consutation with the British Medica Association, the Roya Pharmaceutica Society, the Roya Coege of Nursing, the Medicines and Heathcare Products Reguatory Agency of the Department of Heath, the Competition and Markets Authority and the Serious Fraud Office. Anyone is wecome to send suggestions for amendments or additions to the Code to the PMCPA. It is a condition of membership of the ABPI to abide by the Code in both the spirit and the etter. The Code appies to both members and affiiate members of the ABPI. Companies which are not members of the ABPI may give their forma agreement to abide by the Code and accept the jurisdiction of the PMCPA and over sixty have done so. Thus the Code is accepted by virtuay a pharmaceutica companies operating in the UK. Administering the Code of Practice The Code is administered by the PMCPA which is responsibe for the provision of advice, guidance and training on the Code as we as for the compaints procedure. The PMCPA operates independenty of the ABPI itsef. The reationship between the PMCPA and the ABPI is set out in a protoco of agreement. Financia information about the PMCPA is pubished in its Annua Report. PMCPA pubications can a be found on its website or are suppied on request. Compaints under the Code are considered by the Code of Practice Pane and, where required, by the Code of Practice Appea Board. Reports on competed cases are pubished by the PMCPA in its Code of Practice Review and on its website. The PMCPA aso pubishes a ist of ongoing cases on its website. How to Compain Compaints shoud be submitted to the Director of the Prescription Medicines Code of Practice Authority, 7th Foor, Southside, 105 Victoria Street, London SW1E 6QT, teephone , facsimie , emai compaints@pmcpa.org.uk. 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7 PROVISIONS OF THE CODE OF PRACTICE Cause 1 Scope of the Code and Definition of Certain Terms 1.1 This Code appies to the promotion of medicines to members of the United Kingdom heath professions and to other reevant decision makers. The Code aso appies to a number of areas which are non-promotiona, incuding information made avaiabe to the pubic about prescription ony medicines. It does not appy to the promotion of over-the-counter medicines to members of the heath professions when the object of that promotion is to encourage their purchase by members of the pubic. 1.2 The term promotion means any activity undertaken by a pharmaceutica company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sae, suppy or use of its medicines. It incudes: journa and direct mai advertising the activities of representatives incuding any eectronic or printed materia used by them the suppy of sampes the provision of inducements to prescribe, suppy, administer, recommend, buy or se medicines by the gift, offer or promise of any benefit or bonus, whether in money or in kind the provision of hospitaity for promotiona purposes the sponsorship of promotiona meetings the sponsorship of scientific meetings incuding payment of traveing and accommodation expenses in connection therewith a other saes promotion in whatever form, such as participation in exhibitions, the use of audio or video recordings in any format, broadcast media, non-print media, the Internet, interactive data systems, socia media and the ike. It does not incude: repies made in response to individua enquiries from members of the heath professions or other reevant decision makers or in response to specific communications from them whether of enquiry or comment, incuding etters pubished in professiona journas, but ony if they reate soey to the subject matter of the etter or enquiry, are accurate and do not misead and are not promotiona in nature factua, accurate, informative announcements and reference materia concerning icensed medicines and reating, for exampe, to pack changes, adverse reaction warnings, trade cataogues and price ists, provided they incude no product caims price ists reating to unicensed medicines, provided they incude no product caims and they make cear that the products are unicensed information suppied by pharmaceutica companies to nationa pubic organisations, such as the Nationa Institute for Heath and Care Exceence (NICE), the A Waes Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) is exempt from the Code provided the information is factua, accurate and not miseading measures or trade practices reating to prices, margins or discounts which were in reguar use by a significant proportion of the pharmaceutica industry on 1 January 1993 summaries of product characteristics European pubic assessment reports UK pubic assessment reports the abeing on medicines and accompanying package eafets insofar as they are not promotiona for the medicines concerned; the contents of abes and package eafets are covered by reguations information reating to human heath or diseases provided there is no reference, either direct or indirect, to specific medicines. 1.3 The term medicine means any branded or unbranded medicine intended for use in humans which requires a marketing authorization. 1.4 The term heath professiona incudes members of the medica, denta, pharmacy and nursing professions and any other persons who in the course of their professiona activities may administer, prescribe, purchase, recommend or suppy a medicine. 1.5 The term other reevant decision makers particuary incudes those with an NHS roe who coud infuence in any way the administration, consumption, prescription, purchase, recommendation, sae, suppy or use of any medicine but who are not heath professionas. 1.6 The term over-the-counter medicine means those medicines or particuar packs of medicines which are primariy advertised to the pubic for use in sef medication. 1.7 The term representative means a representative caing on members of the heath professions and other reevant decision makers in reation to the promotion of medicines. 1.8 The term promotiona aid means a non-monetary gift made for a promotiona purpose. 1.9 The term heathcare organisation means either a heathcare, medica or scientific association or organisation such as a hospita, cinic, foundation, university or other teaching institution or earned society whose business address, pace of incorporation or primary pace of operation is in Europe or an organisation through which one or more heath professionas or other reevant decision makers provide services. 6 CODE OF PRACTICE

8 1.10 The term transfer of vaue means a direct or indirect transfer of vaue, whether in cash, in kind or otherwise, made, whether for promotiona purposes or otherwise, in connection with the deveopment or sae of medicines. A direct transfer of vaue is one made directy by a company for the benefit of a recipient. An indirect transfer of vaue is one made by a third party on behaf of a company for the benefit of a recipient where the identity of the company is known to, or can be identified by, the recipient Pharmaceutica companies must compy with a appicabe codes, aws and reguations to which they are subject Each company must appoint a senior empoyee to be responsibe for ensuring that the company meets the requirements of the Code. Cause 1 Suppementary Information Cause 1.1 Scope of the Code For the purposes of the appication of the Code, the United Kingdom incudes the Channe Isands and the Ise of Man. The Code appies to the promotion of medicines to members of the heath professions and to other reevant decision makers as specified in Cause 1.1. This incudes promotion at meetings for UK residents hed outside the UK. It aso appies to promotion to UK heath professionas and other reevant decision makers at internationa meetings hed outside the UK, except that the promotiona materia distributed at such meetings wi need to compy with oca requirements. Some of the requirements of the Code are not necessariy reated to promotion. Exampes incude decarations of sponsorship in Cause 9.10, cinica trias and noninterventiona studies in Cause 13, certain aspects of the provision of medicines and sampes in Cause 17, donations, grants and fees for services in Causes 19.2 and 21, the use of consutants in Cause 23, the provision of information to the pubic in Cause 26 and reations with patient organisations in Cause 27. The Code does not appy to the promotion of over-the-counter medicines to members of the heath professions when the object of that promotion is to encourage their purchase by members of the pubic as specified in Cause 1.1. Thus, for exampe, an advertisement to doctors for an over-the-counter medicine does not come within the scope of the Code if its purpose is to encourage doctors to recommend the purchase of the medicine by patients. Where the advertisement is designed to encourage doctors to prescribe the medicine, then it comes within the scope of the Code. Advertisements for over-the-counter medicines to pharmacists are outside the scope of the Code. Advertisements to pharmacists for other medicines come within the scope of the Code. Cause 1.1 Market Extension Activities which are designed to enarge the market in a particuar therapeutic area, such as disease awareness campaigns, are permitted, provided that these are carried out in a manner compatibe with the Code. Cause 1.1 Joint Working Joint working with the NHS and others is permitted if carried out in a manner compatibe with the Code. Joint working is where, for the benefit of patients, one or more pharmaceutica companies and the NHS poo skis, experience and/or resources for the joint deveopment and impementation of patient centred projects and share a commitment to successfu deivery. The Department of Heath has issued to the NHS Best practice guidance on joint working between the NHS and pharmaceutica industry and other reevant commercia organisations. A tookit, Moving beyond sponsorship: joint working between the NHS and the pharmaceutica industry has been issued by the Department of Heath and the ABPI. The ABPI has produced guidance notes on joint working between pharmaceutica companies and the NHS and others for the benefit of patients. The conduct of joint working is deat with in Cause 20 and its suppementary information. Cause 1.1 Journas with an Internationa Distribution The Code appies to the advertising of medicines in professiona journas which are produced in the UK and/or intended for a UK audience. The identification of the country in which a journa is produced is based on factors such as where it is compied and edited, and where it is typeset, printed and bound, rather than on factors such as the ocation of the head office of the pubisher. Internationa journas which are produced in Engish in the UK are subject to the Code even if ony a sma proportion of their circuation is to a UK audience. It is hepfu in these circumstances to indicate that the information in the advertisement is consistent with the UK marketing authorization. It shoud be noted that the Medicines and Heathcare Products Reguatory Agency s guidance Advertising and Promotion of Medicines in the UK, The Bue Guide, differs from the above by advising that advertising materia in professiona journas intended primariy for circuation in the UK, whether or not in the Engish anguage, must compy with UK egisation and with the UK marketing authorization for the product. Where a journa is produced in the UK but intended for distribution soey to overseas countries, oca requirements and/or the requirements of the Internationa Federation of Pharmaceutica Manufacturers and Associations (IFPMA) Code of Practice shoud be borne in mind. Cause 1.1 Advertising to the Pubic and Advertising Over-the-Counter Medicines to Heath Professionas The promotion of medicines to the pubic for sef medication is covered by the Consumer Code of the Proprietary Association of Great Britain (PAGB) ( The PAGB aso has a Professiona Code which appies to advertising invoving over-the-counter medicines aimed whoy or mainy at persons quaified to prescribe or suppy and appropriate administrative staff, where the object of the advertising is to infuence saes and/or recommendations to the pubic. Cause 1.1 Promotion to Other Reevant Decision Makers The provisions of the Code appy in their entirety to the promotion of medicines to other reevant decision makers except where the text indicates otherwise. This woud incude administrative staff where appropriate. For exampe, the prescribing information required under Cause 4 must be CODE OF PRACTICE 7

9 incuded in promotiona materia provided to other reevant decision makers but it is not permissibe to provide sampes of medicines to them as this is proscribed by Cause Particuar attention is drawn to the provisions of Cause 11.1 and the suppementary information to that cause, which concern the appropriateness of promotiona materia to those to whom it is addressed. Cause 1.2 Repies Intended for Use in Response to Individua Enquiries The exemption for repies made in response to individua enquiries from members of the heath professions or other reevant decision makers reates to unsoicited enquiries ony. An unsoicited enquiry is one without any prompting from the company. In answering an unsoicited enquiry a company can offer to provide further information. If the enquirer subsequenty requests additiona information this can be provided and woud be exempt from the Code provided the additiona information met the requirements of the exemption. A soicited enquiry woud be one where a company invites a person to make a request. For exampe, materia offering further information to readers woud be soiciting a request for that information. Pacing documents on exhibition stands amounts to an invitation to take them. Neither can take the benefit of this exemption. Repies intended for use in response to enquiries which are received on a reguar basis may be drafted in advance provided that they are used ony when they directy and soey reate to the particuar enquiry. Documents must not have the appearance of promotiona materia. Cause 1.2 Price Lists for Unicensed Medicines Price ists of unicensed medicines which incude no product caims and make cear that the products are unicensed can be sent to heath professionas and other reevant decision makers at reasonabe intervas or in response to enquiries. They must not be used proactivey in a manner which coud be seen to be promoting unicensed medicines, such as by dispaying them on exhibition stands. Cause 1.7 Representatives Medica representatives and generic saes representatives are distinguished in the suppementary information to Cause 16.3 reating to examinations for representatives. Cause 1.9 Heathcare Organisations If a heathcare organisation consists of ony one heath professiona or other reevant decision maker then it woud be subject to the requirements in the Code regarding individua heath professionas. Cause 1.10 Excuded Discosures The foowing are not transfers of vaue for the purposes of the Code: transfers of vaue that are soey reated to over-the-counter medicines ordinary course purchases and saes of medicines by and between a company and a heath professiona or a heathcare organisation incuding package deas as defined in the suppementary information to Cause 18.1 sampes of medicines provided in accordance with Cause 17 transfers of vaue provided in accordance with Causes 18.2 and 18.3 subsistence provided to heath professionas in accordance with Cause Cause 1.11 Appicabiity of Codes Pharmaceutica companies must ensure that they compy with a appicabe codes, aws and reguations to which they are subject. This is particuary reevant when activities/ materias invove more than one country or when a pharmaceutica company based in one country is invoved in activities in another country. Activities carried out and materias used by a pharmaceutica company ocated in a European country must compy with the nationa code of that European country as we as the nationa code of the country in which the activities take pace or the materias are used. Activities carried out and materias used in a European country by a pharmaceutica company ocated in a country other than a European country must compy with the EFPIA Code as we as the nationa code of the country in which the activities are carried out and materias are used. For exampe a company ocated in the UK carrying out an activity outside the UK but within Europe, such as in France, must compy with the UK Code and the French Code regardess of whether or not UK heath professionas or other reevant decision makers are invoved. Conversey a company ocated in France carrying out an activity in the UK must compy with the ABPI Code regardess of whether or not UK heath professionas or other reevant decision makers are invoved. Detais of the various codes can be found at or By company is meant any ega entity that organises or sponsors promotion which takes pace within Europe, whether such entity be a parent company (eg the headquarters, principa office, or controing company of a commercia enterprise), subsidiary company or any other form of enterprise or organisation. In the event of a confict of requirements the more restrictive requirements woud appy. There is a potentia exception with regard to the imits for subsistence set in European countries where the nationa association is a member of EFPIA and thus covered by EFPIA Codes as referred to in the suppementary information to Cause A internationa events, that is to say events that take pace outside the responsibe pharmaceutica company s home country, must be notified in advance to any reevant oca subsidiary or oca advice taken. Companies must take reasonabe steps to ensure that any other parties that they commission to design, impement or engage in activities covered by the Code but which do not act on behaf of the company, and are therefore not covered by Cause 1.2, for exampe joint ventures or icensees, compy with the Code. Cause 1.12 Responsibe Person There is an assumption that the responsibe person is the managing director or chief executive or equivaent uness other forma arrangements have been made within the company. 8 CODE OF PRACTICE

10 Cause 2 Discredit to, and Reduction of Confidence in, the Industry Activities or materias associated with promotion must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutica industry. Cause 2 Suppementary Information Cause 2 Discredit to, and Reduction of Confidence in, the Industry A ruing of a breach of this cause is a sign of particuar censure and is reserved for such circumstances. Exampes of activities that are ikey to be in breach of Cause 2 incude prejudicing patient safety and/or pubic heath, excessive hospitaity, inducements to prescribe, unacceptabe payments, inadequate action eading to a breach of undertaking, promotion prior to the grant of a marketing authorization, conduct of company empoyees/agents that fas short of competent care and mutipe/cumuative breaches of a simiar and serious nature in the same therapeutic area within a short period of time. Cause 3 Marketing Authorization 3.1 A medicine must not be promoted prior to the grant of the marketing authorization which permits its sae or suppy. 3.2 The promotion of a medicine must be in accordance with the terms of its marketing authorization and must not be inconsistent with the particuars isted in its summary of product characteristics. Cause 3 Suppementary Information Cause 3 Marketing Authorization The egitimate exchange of medica and scientific information during the deveopment of a medicine is not prohibited provided that any such information or activity does not constitute promotion which is prohibited under this or any other cause. Cause 3 Promotion at Internationa Meetings The promotion of medicines at internationa meetings hed in the UK may on occasion pose certain probems with regard to medicines or indications for medicines which do not have a marketing authorization in the UK athough they are so authorized in another major industriaised country. The dispay and provision of promotiona materia for such medicines is permitted at internationa meetings in the UK provided that the foowing conditions are met: the meeting must be a truy internationa meeting of high scientific standing with a significant proportion of the attendees from countries outside the UK in which the product is icensed the medicine or indication must be reevant and proportiona to the purpose of the meeting promotiona materia for a medicine or indication that does not have a UK marketing authorization must be ceary and prominenty abeed to that effect in reation to an unicensed indication, UK approved prescribing information must be readiy avaiabe for a medicine authorized in the UK even though it wi not refer to the unicensed indication the names must be given of countries in which the medicine or indication is authorized which must incude at east one major deveoped country and it must be stated that registration conditions differ from country to country the materia is certified in accordance with Cause 14, except that the signatories need certify ony that in their beief the materia is a fair and truthfu presentation of the facts about the medicine. Cause 3.1 Advance Notification of New Products or Product Changes which May Significanty Affect Expenditure NHS organisations and others invoved in the purchase of medicines need to estimate their ikey budgets in advance and there is a need for them to receive advance information about the introduction of new medicines, or changes to existing medicines, which may significanty affect their eve of expenditure. At the time this information is required, the medicines concerned (or the changes to them) wi not be the subject of marketing authorizations (though appications wi often have been made) and it woud be in breach of the Code for them to be promoted. Companies wishing to provide advance notification must ensure that information is aso provided wherever possibe for incusion in nationa horizon scanning databases. Non promotiona information can be provided as advance notification but it must: i) reate to: (a) a product which contains a new active substance, or (b) a product which contains an active substance prepared in a new way, such as by the use of biotechnoogy, or (c) a product which is to have a significant addition to the existing range of authorized indications, or (d) a product which is to have a nove and innovative means of administration ii) ony be directed to those responsibe for making poicy decisions on budgets and not those expected to prescribe CODE OF PRACTICE 9

11 iii) state whether or not a new medicine or a change to an existing medicine is the subject of a marketing authorization in the UK iv) state the ikey cost or savings and budgetary impications which must be such that they wi significanty change the organisation s ikey expenditure v) be factua and imited to that sufficient to provide an adequate but succinct account of the product s properties; other products shoud ony be mentioned to put the new product into context in the therapeutic area concerned The information provided must not: i) be promotiona in stye product ogos shoud be avoided but company ogos may be used; the brand name of the product may be incuded in moderation but it shoud not be styised or used to excess ii) incude mock up drafts of either summaries of product characteristics or package eafets. If requested further information may be suppied or a presentation made. Cause 3.2 Unauthorized Indications The promotion of indications not covered by the marketing authorization for a medicine is prohibited by this cause. Cause 4 Prescribing Information and Other Obigatory Information 4.1 The prescribing information isted in Cause 4.2 must be provided in a cear and egibe manner in a promotiona materia for a medicine except for abbreviated advertisements (see Cause 5). The prescribing information must be positioned for ease of reference and must not be presented in a manner such that the reader has to turn the materia round in order to read it, for exampe by providing it diagonay or around the page borders. The prescribing information must form part of the promotiona materia and must not be separate from it. 4.2 The prescribing information consists of the foowing: the ega cassification of the product the cost (excuding VAT) of either a specified package of the medicine to which the advertisement reates, or a specified quantity or recommended daiy dose, cacuated by reference to any specified package of the product, except in the case of advertisements in journas printed in the UK which have more than 15 per cent of their circuation outside the UK and audiovisua advertisements and prescribing information provided in association with them and i) the name of the medicine (which may be either a brand name or a non-proprietary name) ii) iii) a quantitative ist of the active ingredients, using approved names where such exist, or other nonproprietary names; aternativey, the nonproprietary name of the product if it is the subject of an accepted monograph at east one authorized indication for use consistent with the summary of product characteristics iv) a succinct statement of the information in the summary of product characteristics reating to the dosage and method of use reevant to the indications quoted in the advertisement and, where not otherwise obvious, the route of administration v) a succinct statement of common adverse reactions ikey to be encountered in cinica practice, serious adverse reactions and precautions and contra-indications reevant to the indications in the advertisement, giving, in an abbreviated form, the substance of the reevant information in the summary of product characteristics, together with a statement that prescribers shoud consut the summary of product characteristics in reation to other adverse reactions vi) any warning issued by the Medicines Commission, the Commission on Human Medicines, the Committee on Safety of Medicines or the icensing authority, which is required to be incuded in advertisements vii) the number of the reevant marketing authorization and the name and address of the hoder of the authorization or the name and address of the part of the business responsibe for its sae or suppy viii) the date the prescribing information was drawn up or ast revised. The summary of product characteristics may be provided instead of i-viii above. If the summary of product characteristics is not used then the information specified above in reation to iv, v, and vi which is required to be incuded in advertisements, must be paced in such a position in the advertisement that its reationship to the caims and indications for the product can be appreciated by the reader 4.3 In addition, the non-proprietary name of the medicine or a ist of the active ingredients using approved names where such exist must appear immediatey adjacent to the most prominent dispay of the brand name in bod type of a size such that a ower case x is no ess than 2mm in height or in type of such a size that the nonproprietary name or ist of active ingredients occupies a tota area no ess than that taken up by the brand name. 10 CODE OF PRACTICE

12 For eectronic advertisements the non-proprietary name of the medicine or the ist of active ingredients, as required by Cause 4.3, must appear immediatey adjacent to the brand name at its first appearance in a size such that the information is readiy readabe. 4.4 In the case of digita materia such as advertisements in eectronic journas, emais, eectronic detai aids and such ike, the prescribing information as required by Cause 4.1 may be provided either: by incusion in the digita materia itsef or by way of a cear and prominent direct singe cick ink. 4.5 In the case of audio-visua materia such as fims, DVDs and suchike and in the case of interactive data systems, the prescribing information may be provided either: by way of a document which is made avaiabe to a persons to whom the materia is shown or sent, or by incusion on the audio-visua recording or in the interactive data system itsef. When the prescribing information is incuded in an interactive data system instructions for accessing it must be ceary dispayed. 4.6 In the case of promotiona materia incuded on the Internet, there must be a cear, prominent statement as to where the prescribing information can be found. 4.7 In the case of a printed journa advertisement where the prescribing information appears overeaf, at either the beginning or the end of the advertisement, a reference to where it can be found must appear on the outer page of the other page of the advertisement in a type size such that a ower case x is no ess than 2mm in height. 4.8 In the case of printed promotiona materia consisting of more than four pages, a cear reference must be given to where the prescribing information can be found. 4.9 Promotiona materia other than advertisements appearing in professiona pubications must incude the date on which the promotiona materia was drawn up or ast revised A promotiona materia must incude the prominent statement Adverse events shoud be reported. Reporting forms and information can be found at Adverse events shoud aso be reported to [reevant pharmaceutica company] When required by the icensing authority, a promotiona materia must show an inverted back equiatera triange to denote that additiona monitoring is required in reation to adverse reactions. Cause 4 Suppementary Information Cause 4.1 Prescribing Information and Summaries of Product Characteristics Each promotiona item for a medicine must be abe to stand aone. For exampe, when a Dear Doctor etter on a medicine is sent in the same enveope as a brochure about the same medicine, each item has to incude the prescribing information. It does not suffice to have the prescribing information on ony one of the items. The incusion of a separate summary of product characteristics is not sufficient to conform with the provisions of this cause. There may be instances where reproducing the summary of product characteristics wi not be an acceptabe way to fufi the requirement for prescribing information. For exampe, Cause 6.3 imits advertising in journas for a particuar product to two pages. The prescribing information must be consistent with the summary of product characteristics for the medicine. Cause 4.1 Legibiity of Prescribing Information The prescribing information is the essentia information which must be provided in promotiona materia. It foows therefore that the information must be given in a cear and egibe manner which assists readabiity. Legibiity is not simpy a question of type size. The foowing recommendations wi hep to achieve carity: type size shoud be such that a ower case x is no ess than 1 mm in height ines shoud be no more than 100 characters in ength, incuding spaces sufficient space shoud be aowed between ines to faciitate easy reading a cear stye of type shoud be used there shoud be adequate contrast between the coour of the text and the background dark print on a ight background is preferabe embodening headings and starting each section on a new ine aids egibiity. Causes 4.1 and 4.9 Date of Prescribing Information and Promotiona Materia If the summary of product characteristics is not used then the date that the prescribing information was ast drawn up or ast revised must be incuded (Cause 4.2 viii). In addition, promotiona materia (other than journa advertising) must incude the date that the materia as a whoe, ie the copy pus the prescribing information, was drawn up or ast revised. Cause 4.1 Eectronic Journas The first part of an advertisement in an eectronic journa, such as the banner, is often the ony part of the advertisement that is seen by readers. It must therefore incude a cear, prominent statement as to where the prescribing information can be found. This shoud be in the form of a direct ink. The first part is often inked to other parts and in such circumstances the inked parts wi be considered as one advertisement. If the first part mentions the product name then this is the most prominent dispay of the brand name and the non-proprietary name of the medicine or a ist of the active ingredients using approved names where such exist must appear immediatey adjacent to the most prominent dispay of the brand name. The size must be such that the information is easiy readabe. If the product is one that is required to show an inverted back equiatera triange on its promotiona materia then the back triange symbo must aso appear adjacent to the product name (see Cause 4.11). The size must be such that it is easiy CODE OF PRACTICE 11

13 readabe. The requirement of Cause 12.1 that promotiona materia and activities must not be disguised shoud aso be borne in mind. Cause 4.1 Advertisements for Devices Where an advertisement reates to the merits of a device used for administering medicines, such as an inhaer, which is suppied containing a variety of medicines, the prescribing information for one ony need be given if the advertisement makes no reference to any particuar medicine. Fu prescribing information must, however, be incuded in reation to each particuar medicine which is referred to. Cause 4.1 Prescribing Information at Exhibitions The prescribing information for medicines promoted on posters and exhibition panes at meetings must either be provided on the posters or panes themseves or must be avaiabe at the company stand. If the prescribing information is made avaiabe at the company stand, this shoud be referred to on the posters or panes. Cause 4.3 Non-Proprietary Name Immediatey adjacent to means immediatey before, immediatey after, immediatey above or immediatey beow. It shoud be noted that in a promotiona etter the most prominent dispay of the brand name wi usuay be that in the etter itsef, rather than that in prescribing information provided on the reverse of the etter. Cause 4.4 Use of Links for Prescribing Information When digita materia provides the reader with a ink to prescribing information on another website then such a ink shoud ony be incuded for use when the materia is generay expected to be viewed onine, for exampe, advertisements in eectronic journas or eectronic detai aids when used remotey and the ike. This is to ensure that at the time of reading the ink is active and wi provide readers with the necessary information. When materia is more ikey to be viewed offine, such as eectronic detai aids to be used by representatives when visiting heath professionas, emais and the ike, then the requisite information must be provided as part of the item itsef or as a ink that does not require the reader to be onine. Cause 4.5 Prescribing Information on Audio-Visua Materia Where prescribing information is shown in the audio-visua materia as part of the recording, it must be of sufficient carity and duration so that it is easiy readabe. The prescribing information must be an integra part of the advertisement and must appear with it. It is not acceptabe Cause 5 Abbreviated Advertisements 5.1 Abbreviated advertisements are advertisements which are exempt from the requirement to incude prescribing information for the advertised medicine, provided that they meet with the requirements of this cause. 5.2 Abbreviated advertisements may ony appear in professiona pubications ie pubications sent or deivered whoy or mainy to members of the heath professions and/or other reevant decision makers. A oose insert in such a pubication cannot be an abbreviated advertisement. for the advertisement and the prescribing information to be separated by any other materia. Cause 4.9 Date Drawn Up or Last Revised This is in addition to the requirement in Cause 4.2 that the date of the prescribing information be incuded. Cause 4.9 Dates on Loose Inserts A oose insert is not regarded for this purpose as appearing in the professiona pubication with which it is sent and must therefore bear the date on which it was drawn up or ast revised. Cause 4.10 Adverse Event Reporting A teephone number or emai address for the reevant department of the company may be incuded. Text is more ikey to be deemed to be prominent if it is presented in a arger type size than that used for the prescribing information. In the event that the website address given in Cause 4.10 is changed by the Medicines and Heathcare Products Reguatory Agency, companies may use a statement incorporating the new address as soon as the change is made and must use the new address within one year of the change. Cause 4.11 Back Triange Symbo The agreement between the then Committee on Safety of Medicines and the ABPI on the use of the back triange is that: The symbo shoud aways be back and its size shoud normay be not ess than 5mm per side but with a smaer size of 3mm per side for A5 size advertisements and a arger size of 7.5mm per side for A3 size advertisements: the symbo shoud appear once and be ocated adjacent to the most prominent dispay of the name of the product no written expanation of the symbo is necessary. Digita communications are aso covered by this requirement and the back triange symbo shoud be ocated adjacent to the first mention of the product as this is ikey to be considered the most prominent dispay of the name of the product. The size must be such that it is easiy readabe. Summaries of product characteristics and package eafets are excuded from the definition of promotion in the Code by Cause 1.2. However it shoud be noted that EU egisation now requires the back triange symbo to appear on summaries of product characteristics and on package eafets. The size of the back triange on these documents has to be proportionate to the font size of the subsequent text with a minimum ength of 5mm per side. The EU requirements do not appy to promotiona materia. Obigatory expanatory wording is aso required. Abbreviated advertisements may contain ony the information specified in Causes 5.4, 5.5, 5.6, 5.7 and 5.8. Abbreviated advertisements are not permitted in audiovisua materia or in interactive data systems or on the Internet, incuding journas on the Internet. 5.3 Abbreviated advertisements must be no arger than 420 square centimetres in size. 5.4 Abbreviated advertisements must provide the foowing information in a cear and egibe manner: the name of the medicine (which may be either a brand name or a non-proprietary name) 12 CODE OF PRACTICE