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 [email protected]. 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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

14 the non-proprietary name of the medicine or a ist of the active ingredients using approved names where such exist at east one indication for use consistent with the summary of product characteristics the ega cassification of the product 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 the name and address of the hoder of the marketing authorization or the name and address of the part of the business responsibe for its sae or suppy abbreviated advertisements must incude the statement Information about this product, incuding adverse reactions, precautions, contra-indications and method of use can be found at [the address of the website referred to beow] and state that prescribers are recommended to consut the summary of product characteristics before prescribing. The foowing information must be provided on the website referred to above: either, the information set out in Causes 4.2 and 4.3 (except that 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 most prominent dispay of the brand name in a size such that the information is readiy readabe and information about cost as required by Cause 4.2 need not be incuded on the website where the abbreviated advertisement appears ony in journas printed in the UK which have more than 15 per cent of their circuation outside the UK), or, the summary of product characteristics. 5.5 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. 5.6 In addition, abbreviated advertisements 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]. 5.7 When required by the icensing authority, abbreviated advertisements must show an inverted back equiatera triange to denote that additiona monitoring is required in reation to adverse reactions. 5.8 Abbreviated advertisements may in addition contain a concise statement consistent with the summary of product characteristics, giving the reason why the medicine is recommended for the indication or indications given. 5.9 Marketing authorization numbers and references must not be incuded in abbreviated advertisements. Cause 5 Suppementary Information Cause 5.2 Professiona Pubications Abbreviated advertisements are argey restricted to journas and other such professiona pubications sent or deivered whoy or mainy to members of the heath professions etc. A promotiona maiing or representative eavepiece cannot be an abbreviated advertisement and an abbreviated advertisement cannot appear as part of another promotiona item, such as in a brochure consisting of a fu advertisement for another of the company's medicines. DVDs and suchike sent to doctors etc may be considered professiona pubications and an abbreviated advertisement may be incuded on a box containing a DVD. The prescribing information must, however, be made avaiabe for any advertisement for a medicine appearing on audio-visua materia or in an interactive data system or on the Internet, incuding journas on the Internet. Such advertisements cannot be deemed abbreviated advertisements. Causes 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9 Permitted Information The contents of abbreviated advertisements are restricted as set out in Causes 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9 and the foowing information shoud not therefore be incuded in abbreviated advertisements: dosage particuars detais of pack sizes cost. There may be exceptions to the above if the information provided, for exampe the cost of the medicine or the frequency of its dosage or its avaiabiity as a patient pack, is given as the reason why the medicine is recommended for the indication or indications referred to in the advertisement. Artwork used in abbreviated advertisements must not convey any information about a medicine which is additiona to that permitted under Causes 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9. Teephone numbers may be incuded in abbreviated advertisements. Cause 5.5 Non-Proprietary Name Immediatey adjacent to means immediatey before, immediatey after, immediatey above or immediatey beow. Cause 5.6 Adverse Event Reporting A teephone number or emai address for the reevant department of the company may be incuded. In the event that the website address given in Cause 5.6 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 5.7 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: CODE OF PRACTICE 13

15 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. It shoud be borne in mind that abbreviated advertisements must be no arger than 420 square centimetres in size. In abbreviated advertisements of no more than square centimetres (A5) each side shoud be no ess than 3mm. In abbreviated advertisements arger than A5 (but no arger than 420 square centimetres) each side shoud be no ess than 5mm. Cause 6 Journa Advertising 6.1 Where the pages of a two page advertisement are not facing, neither must be fase or miseading when read in isoation. 6.2 No advertisement taking the form of a oose insert in a journa may consist of more than a singe sheet of a size no arger than the page size of the journa itsef, printed on one or both sides. 6.3 No issue of a journa may bear advertising for a particuar product on more than two pages. Cause 6 Suppementary Information Cause 6 Journa Advertisements See Cause 4 and in particuar Cause 4.7 regarding the requirements for prescribing information in journa advertisements. A two page journa advertisement is one where the pages foow on without interruption by intervening editoria text Cause 7 Information, Caims and Comparisons 7.1 Upon reasonabe request, a company must prompty provide members of the heath professions and other reevant decision makers with accurate and reevant information about the medicines which the company markets. 7.2 Information, caims and comparisons must be accurate, baanced, fair, objective and unambiguous and must be based on an up-to-date evauation of a the evidence and refect that evidence ceary. They must not misead either directy or by impication, by distortion, exaggeration or undue emphasis. Materia must be sufficienty compete to enabe the recipient to form their own opinion of the therapeutic vaue of the medicine. 7.3 A comparison is ony permitted in promotiona materia if: it is not miseading medicines or services for the same needs or intended for the same purpose are compared or other copy. Thus, for exampe, promotiona materia on two successive right hand pages cannot be a singe advertisement. Each such page woud need to be treated as a separate advertisement for the purposes of prescribing information. Simiary, if promotiona materia appears on the outer edges of the eft and right hand pages of a doube page spread, and the promotiona materia is separated by intervening editoria matter, then again each page woud need to be treated as a separate advertisement. Cause 6.2 Advertising on the Outside of Journas Advertising such as cards staped to a journa and wraparounds must not have a greater surface area than that outined for oose inserts under Cause 6.2. Cause 6.3 Limitation on Number of Pages of Advertising Advertisements taking the form of inserts, whether oose or bound in, count towards the two pages aowed by Cause 6.3. An insert printed on both sides counts as two pages. A summary of product characteristics is permitted as an insert in addition to the two pages of advertising which is aowed. Inserts and suppements which are not advertisements as such, though they may be regarded as promotiona materia, for exampe reports of conference proceedings, are not subject to the restrictions of Causes 6.2 and 6.3. one or more materia, reevant, substantiabe and representative features are compared no confusion is created between the medicine advertised and that of a competitor or between the advertiser s trade marks, trade names, other distinguishing marks and those of a competitor the trade marks, trade names, other distinguishing marks, medicines, services, activities or circumstances of a competitor are not discredited or denigrated no unfair advantage is taken of the reputation of a trade mark, trade name or other distinguishing marks of a competitor medicines or services are not presented as imitations or repicas of goods or services bearing a competitor s trade mark or trade name. 7.4 Any information, caim or comparison must be capabe of substantiation. 7.5 Substantiation for any information, caim or comparison must be provided as soon as possibe, and certainy within ten working days, at the request of members of the heath professions or other reevant decision makers. The vaidity of indications approved in the marketing authorization can be substantiated by provision of the summary of product characteristics. 14 CODE OF PRACTICE

16 7.6 When promotiona materia refers to pubished studies, cear references must be given. 7.7 When promotiona materia refers to data on fie, the reevant part of this data must be provided without deay at the request of members of the heath professions or other reevant decision makers. 7.8 A artwork incuding iustrations, graphs and tabes must conform to the etter and spirit of the Code and, when taken from pubished studies, a reference must be given. Graphs and tabes must be presented in such a way as to give a cear, fair, baanced view of the matters with which they dea, and must not be incuded uness they are reevant to the caims or comparisons being made. 7.9 Information and caims about adverse reactions must refect avaiabe evidence or be capabe of substantiation by cinica experience. It must not be stated that a product has no adverse reactions, toxic hazards or risks of addiction or dependency. The word safe must not be used without quaification Promotion must encourage the rationa use of a medicine by presenting it objectivey and without exaggerating its properties. Exaggerated or a-embracing caims must not be made and superatives must not be used except for those imited circumstances where they reate to a cear fact about a medicine. Caims shoud not impy that a medicine or an active ingredient has some specia merit, quaity or property uness this can be substantiated The word new must not be used to describe any product or presentation which has been generay avaiabe, or any therapeutic indication which has been promoted, for more than tweve months in the UK. Cause 7 Suppementary Information Cause 7 Genera The appication of this cause is not imited to information or caims of a medica or scientific nature. It incudes, inter aia, information or caims reating to pricing and market share. Thus, for exampe, any caim reating to the market share of a product must be substantiated without deay upon request as required under Cause 7.5. It shoud be borne in mind that caims in promotiona materia must be capabe of standing aone as regards accuracy etc. In genera caims shoud not be quaified by the use of footnotes and the ike. Cause 7.2 Miseading Information, Caims and Comparisons The foowing are areas where particuar care shoud be taken by companies: caims for superior potency in reation to weight are generay meaningess and best avoided uness they can be inked with some practica advantage, for exampe, reduction in adverse reactions or cost of effective dosage the use of data derived from in-vitro studies, studies in heathy vounteers and in animas. Care must be taken with the use of such data so as not to misead as to its significance. The extrapoation of such data to the cinica situation shoud ony be made where there is data to show that it is of direct reevance and significance reference to absoute risk and reative risk. Referring ony to reative risk, especiay with regard to risk reduction, can make a medicine appear more effective than it actuay is. In order to assess the cinica impact of an outcome, the reader aso needs to know the absoute risk invoved. In that regard reative risk shoud never be referred to without aso referring to the absoute risk. Absoute risk can be referred to in isoation economic evauation of medicines. Care must be taken that any caim invoving the economic evauation of a medicine is borne out by the data avaiabe and does not exaggerate its significance To be acceptabe as the basis of promotiona caims, the assumptions made in an economic evauation must be cinicay appropriate and consistent with the marketing authorization emerging cinica or scientific opinion. Where a cinica or scientific issue exists which has not been resoved in favour of one generay accepted viewpoint, particuar care must be taken to ensure that the issue is treated in a baanced manner in promotiona materia hanging comparisons whereby a medicine is described as being better or stronger or suchike without stating that with which the medicine is compared must not be made price comparisons. Price comparisons, as with any comparison, must be accurate, fair and must not misead. Vaid comparisons can ony be made where ike is compared with ike. It foows therefore that a price comparison shoud be made on the basis of the equivaent dosage requirement for the same indications. For exampe, to compare the cost per m for topica preparations is ikey to misead uness it can be shown that their usage rates are simiar or, where this is not possibe, for the comparison to be quaified in such a way as to indicate that usage rates may vary statistica information. Care must be taken to ensure that there is a sound statistica basis for a information, caims and comparisons in promotiona materia. Differences which do not reach statistica significance must not be presented in such a way as to misead Instances have occurred where caims have been based on pubished papers in which the arithmetic and/or statistica methodoogy was incorrect. Accordingy, before statistica information is incuded in promotiona materia it must have been subjected to statistica appraisa. Cause 7.3 Comparisons The Code does not precude the use of other companies brand names when making comparisons. Cause 7.5 Data from Cinica Trias Companies must provide substantiation foowing a request for it, as set out in Cause 7.5. In addition, when data from a cinica tria is used companies must ensure that where necessary that tria has been registered and the resuts discosed in accordance with Cause Cause 7.6 References Cause 7.6 appies to references to pubished materia, incuding the use of quotations, tabes, graphs and artwork. CODE OF PRACTICE 15

17 Cause 7.8 Artwork, Iustrations, Graphs and Tabes Care must be taken to ensure that artwork does not misead as to the nature of a medicine or any caim or comparison and that it does not detract from any warnings or contraindications. For exampe, anatomica drawings used to show resuts from a study must not exaggerate those resuts and depictions of chidren shoud not be used in reation to products not authorized for use in chidren in any way which might encourage such use. Particuar care shoud be taken with graphs and tabes to ensure that they do not misead, for exampe by their incompeteness or by the use of suppressed zeros or unusua scaes. Differences which do not reach statistica significance must not be presented in such a way as to misead. Graphs and tabes must be adequatey abeed so that the information presented can be readiy understood. When taken from pubished studies, the source of the artwork must be given (see aso Cause 7.6). If a graph, tabe or suchike is taken from a pubished study it must be faithfuy reproduced except where modification is needed in order to compy with the Code. In such circumstances it must be ceary stated that the materia has been modified. Any such adaptation must not distort or misead as to the significance of that graph, tabe etc. Care shoud be taken not to misead when expressing data as percentages; patient numbers shoud be incuded wherever possibe. It shoud aso be noted that if a tabe, graph etc in a paper is unacceptabe in terms of the requirements of the Code, because, for exampe, it gives a visuay miseading impression as to the data shown, then it must not be used or reproduced in promotiona materia. Cause 7.9 Use of the Word Safe The restrictions on the word safe appy equay to grammatica derivatives of the word such as safety. For exampe, demonstrated safety or proven safety are prohibited under this cause. Cause 7.10 Benefit/Risk Profie The benefit/risk profie of a medicine must be presented in promotiona campaigns in such a way as to compy with the Code. Particuar attention shoud be paid to Causes 7.2, 7.9 and Cause 7.10 Superatives Superatives are those grammatica expressions which denote the highest quaity or degree, such as best, strongest, widest etc. A caim that a product was the best treatment for a particuar condition, for exampe, coud not be substantiated as there are too many variabes to enabe such a sweeping caim to be proven. The use of a superative is acceptabe ony if it can be substantiated as a simpe statement of fact which can be very ceary demonstrated, such as that a particuar medicine is the most widey prescribed in the UK for a certain condition, if this is not presented in a way which miseads as to its significance. Cause 7.10 Use of the Words The and Unique In certain circumstances the can impy a specia merit, quaity or property for a medicine which is unacceptabe under this cause if it cannot be substantiated. For exampe, a caim that a product is The anagesic impies that it is in effect the best, and might not be acceptabe. Simiary, care needs to be taken with the use of unique. Athough unique may sometimes be used to describe some ceary defined specia feature of a medicine, often it may simpy impy a genera superiority. In such instances it is not possibe to substantiate the caim as the caim itsef is so i defined. Cause 8 Disparaging References 8.1 The medicines, products and activities of other pharmaceutica companies must not be disparaged. 8.2 The heath professions and the cinica and scientific opinions of heath professionas must not be disparaged. Cause 9 High Standards, Format, Suitabiity and Causing Offence, Sponsorship 9.1 High standards must be maintained at a times. 9.2 A materia and activities must recognise the specia nature of medicines and the professiona standing of the audience to which they are directed and must not be ikey to cause offence. Cause 8 Suppementary Information Cause 8.1 Disparaging References Much pharmaceutica advertising contains comparisons with other products and, by the nature of advertising, such comparisons are usuay made to show an advantage of the advertised product over its comparator. Provided that such critica references to another company s products are accurate, baanced, fair etc, and can be substantiated, they are acceptabe under the Code. Unjustified knocking copy in which the products or activities of a competitor are unfairy denigrated is prohibited under this cause. Attention is drawn to the requirements for comparisons set out in Causes 7.2 to The name or photograph of a member of a heath profession must not be used in any way that is contrary to the conventions of that profession. 9.4 Promotiona materia must not imitate the devices, copy, sogans or genera ayout adopted by other companies in a way that is ikey to misead or confuse. 9.5 Promotiona materia must not incude any reference to the Commission on Human Medicines, the Medicines and Heathcare Products Reguatory Agency or the icensing authority, uness this is specificay required by the icensing authority. 16 CODE OF PRACTICE

18 9.6 Reproductions of officia documents must not be used for promotiona purposes uness permission has been given in writing by the appropriate body. 9.7 Extremes of format, size or cost of materia must be avoided. Informationa or educationa materias must be inexpensive, directy reevant to the practice of medicine or pharmacy and directy beneficia to the care of patients. 9.8 Postcards, other exposed maiings, enveopes or wrappers must not carry matter which might be regarded as advertising to the pubic, contrary to Cause The teephone, text messages, emai, teemessages, facsimie, automated caing systems and other eectronic data communications must not be used for promotiona purposes, except with the prior permission of the recipient Materia reating to medicines and their uses, whether promotiona or not, and information reating to human heath or diseases which is sponsored by a pharmaceutica company must ceary indicate that it has been sponsored by that company. The ony exception to this is market research materia which need not revea the name of the company invoved but must state that it is sponsored by a pharmaceutica company. Cause 9 Suppementary Information Causes 9.1 and 9.2 Suitabiity and Taste The specia nature of medicines and the professiona audience to which the materia is directed require that the standards set for the promotion of medicines are higher than those which might be acceptabe for genera commodity advertising. It foows therefore that certain types, styes and methods of promotion, even where they might be acceptabe for the promotion of products other than medicines, are unacceptabe. These incude: the dispay of naked or partiay naked peope for the purpose of attracting attention to the materia or the use of sexua imagery for that purpose teaser advertising whereby promotiona materia is intended to tease the recipient by eiciting an interest in something which wi be foowing or wi be avaiabe at a ater date without providing any actua information about it the use of inappropriate anguage abbreviations or emoticons particuary in digita communications the provision of private prescription forms preprinted with the name of a medicine. Cause 9.5 MHRA Drug Safety Update Where factua safety information given in promotiona materia is based on advice in the MHRA Drug Safety Update, the information can be referenced to that pubication. Cause 9.7 Extremes of Format, Size or Cost Particuar care needs to be taken in this regard in the first six months foowing the aunch of a medicine to avoid criticism of the industry. Cause 9.8 Repy Paid Cards Repy paid cards which are intended to be returned to companies through the post and which reate to a prescription ony medicine shoud not bear both the name of the medicine and information as to its usage but may bear one or the other. Cause 9.9 Unsubscribing to emais Where permission to use emais for promotiona purposes has been given by a recipient, each emai sent shoud inform the recipient as to how to unsubscribe to them. Cause 9.9 Responding to emais An unsoicited enquiry received by emai or an unsoicited enquiry received by post which incudes an emai address can be responded to by emai without specific permission, consent to do so being impied in such circumstances. There is no need to inform recipients as to how to unsubscribe to an emai response to an enquiry. Cause 9.9 Remote Detaiing When promotion is carried out remotey, such as by teephone ca, web chat or other onine cas, prior permission from the recipient must be obtained in advance or at the start of the contact or ca. In setting up the contact or ca, fu detais must be given of the company the caer wi represent, their roe and the purpose of the ca. Arrangements made to discuss a specific product shoud be adhered to. Cause 9.10 Decaration of Sponsorship The decaration of sponsorship must be sufficienty prominent to ensure that readers of sponsored materia are aware of it at the outset. The wording of the decaration must be unambiguous so that readers wi immediatey understand the extent of the company s invovement and infuence over the materia. This is particuary important when companies are invoved in the production of materia which is circuated by an otherwise whoy independent party, such as suppements to heath professiona journas. Cause 9.10 Market Research Where market research is carried out by an agency on behaf of a pharmaceutica company, the agency must revea the name of its cient to the Prescription Medicines Code of Practice Authority when the Authority requests it to do so. When commissioning market research, a company must take steps to ensure that its identity woud be so made known to the Authority shoud a request for that information be made. CODE OF PRACTICE 17

19 Cause 10 Provision of Reprints and the Use of Quotations 10.1 Reprints of artices in journas must not be provided unsoicited uness the artices have been refereed Quotations from medica and scientific iterature or from persona communications must be faithfuy reproduced (except where adaptation or modification is required in order to compy with the Code) and must accuratey refect the meaning of the author. The precise source of the quotation must be identified Quotations reating to medicines taken from pubic broadcasts, for exampe on radio and teevision, and from private occasions, such as medica conferences or symposia, must not be used without the forma permission of the speaker The utmost care must be taken to avoid ascribing caims or views to authors when these no onger represent the current views of the authors concerned. Cause 10 Suppementary Information Cause 10.1 Provision of Reprints The provision of an unsoicited reprint of an artice about a medicine constitutes promotion of that medicine and a reevant requirements of the Code must therefore be observed. Particuar attention must be paid to the requirements of Cause 3. When providing an unsoicited reprint of an artice about a medicine, it shoud be accompanied by prescribing information. Cause 10.2 Quotations Any quotation chosen by a company for use in promotiona materia must compy with the requirements of the Code itsef. For exampe, to quote from a paper which stated that a certain medicine was safe and effective woud not be acceptabe even if it was an accurate refection of the meaning of the author of the paper, as it is prohibited under Cause 7.9 to state without quaification in promotiona materia that a medicine is safe. Quotations can ony be adapted or modified in order to compy with the Code. In such circumstances it must be ceary stated that the quotation has been amended. Care shoud be taken in quoting from any study or the ike to ensure that it does not misead as to its overa significance. (See Cause 7.2 which prohibits miseading information, caims etc in promotiona materia.) Attention is drawn to the provisions of Cause 7.6 which requires that when promotiona materia refers to pubished studies cear references must be given to where they can be found. Cause 10.4 Current Views of Authors If there is any doubt as to the current view of an author, companies shoud check with the author prior to its use in promotiona materia. Cause 11 Distribution of Materia 11.1 Materia shoud ony be sent or distributed to those categories of persons whose need for, or interest in, it can reasonaby be assumed Restraint must be exercised on the frequency of distribution and on the voume of promotiona materia distributed Maiing ists must be kept up-to-date. Requests to be removed from promotiona maiing ists must be compied with prompty and no name may be restored except at the addressee s request or with their permission. Cause 11 Suppementary Information Cause 11.1 Distribution of Promotiona Materia Promotiona materia shoud be taiored to the audience to whom it is directed. For exampe, promotiona materia devised for genera practitioners might not be appropriate for hospita doctors and, simiary, materia devised for cinicians might not be appropriate for use with other reevant decision makers. Cause 11.2 Frequency of Maiings The stye of maiings is reevant to their acceptabiity to doctors and criticism of their frequency is most ikey to arise where their informationa content is imited. In the first six months foowing the aunch of a new medicine, a heath professiona may be sent an initia maiing giving detaied information about its use, incuding, for exampe, the summary of product characteristics, the pubic assessment report, the package eafet and the product monograph, and no more than three other maiings about the medicine. No more than eight maiings for a particuar medicine may be sent to a heath professiona in a year. Maiings concerned soey with safety issues can be sent in addition to the above as can maiings about price changes which contain no product caims. The imitations on frequency of maiings do not appy to emais as these can ony be sent with the prior permission of the recipient. 18 CODE OF PRACTICE

20 Cause 12 Disguised Promotion 12.1 Promotiona materia and activities must not be disguised Market research activities, cinica assessments, postmarketing surveiance and experience programmes, post-authorization studies (incuding those that are retrospective in nature) and the ike must not be disguised promotion. They must be conducted with a primariy scientific or educationa purpose. Cause 12 Suppementary Information Cause 12.1 Disguised Promotiona Materia Promotiona materia sent in the guise of persona communications, for exampe by using enveopes or postcards addressed in rea or facsimie handwriting, is inappropriate. Enveopes must not be used for the dispatch of promotiona materia if they bear words impying that the contents are non-promotiona, for exampe that the contents provide information reating to safety. Simiary, promotiona materia sent eectronicay such as emais must not give the impression that it is non promotiona. In addition the identity of the responsibe pharmaceutica company must be obvious. When a company pays for, or otherwise secures or arranges Cause 13 Cinica Trias and Non-Interventiona Studies of Marketed Medicines 13.1 Companies must discose detais of cinica trias in accordance with the Joint Position on the Discosure of Cinica Tria Information via Cinica Tria Registries and Databases and the Joint Position on the Pubication of Cinica Tria Resuts in the Scientific Literature A non-interventiona study of a marketed medicine is defined as a study where the medicine is prescribed in the usua manner in accordance with the terms of its marketing authorization. The assignment of the patient to a particuar therapeutic strategy is not decided by a study protoco but fas within current practice and the prescription of the medicine is ceary separated from the decision to incude the patient in the study. No additiona diagnostic or monitoring procedures are appied to the patients and epidemioogica methods are used for the anaysis of coected data Companies must pubish the summary detais and resuts of non-interventiona studies of marketed medicines in a manner consistent with their parae obigations with respect to cinica trias Non-interventiona studies that are prospective in nature and invove the coection of patient data must be conducted for a scientific purpose. They must compy with the foowing criteria: the pubication of promotiona materia in journas, such materia must not resembe independent editoria matter. Care must be taken with company sponsored reports of meetings and the ike to ensure that they are not disguised promotion. Sponsorship must be decared in accordance with Cause Cause 12.2 Non-Interventiona Studies of Marketed Medicines The conduct of non-interventiona studies of marketed medicines is deat with in Cause 13. Cause 12.2 Market Research Market research is the coection and anaysis of information and must be unbiased and non-promotiona. The use to which the statistics or information is put may be promotiona. The two phases must be kept distinct. Attention is drawn to the Lega & Ethica Guideines for Heathcare Market Research produced by the British Heathcare Business Inteigence Association in consutation with the ABPI. Market research materia shoud be examined to ensure that it does not contravene the Code. Where market research is carried out by an agency on behaf of a pharmaceutica company, the agency must revea the name of its cient to the Prescription Medicines Code of Practice Authority when the Authority requests it to do so. When commissioning market research, a company must take steps to ensure that its identity woud be so made known to the Authority shoud a request for that information be made. there must be a written protoco and written contracts between the heath professionas and/or the institutes at which the study wi take pace and the pharmaceutica company sponsoring the study, which specify the nature of the services to be provided and the payment for those services any remuneration must be reasonabe and refect the fair market vaue of the work in countries where ethics committees are prepared to review such studies, the study protoco must be submitted to the ethics committee for review data protection egisation must be compied with the study must not constitute an inducement to prescribe, suppy, administer, recommend, buy or se any medicine the company s scientific service must approve the protoco and must supervise the conduct of the study the study resuts must be anaysed and summaries must be made avaiabe within a reasonabe period of time to the company s scientific service, which service sha maintain records of such reports; the summary report shoud be sent to heath professionas who participated in the study. If the study resuts are important for the assessment of benefit/risk, the summary report shoud be immediatey forwarded to the reevant competent authority CODE OF PRACTICE 19

21 saes representatives may ony be invoved in an administrative capacity and such invovement must be under the supervision of the company s scientific service which wi aso ensure that the representatives are adequatey trained for the roe; such invovement must not be inked to the promotion of any medicine. Cause 13 Suppementary Information Cause 13 Good Pharmacovigiance Practices Attention is drawn to the Good pharmacovigiance practices page on the European Medicines Agency website. ( Cause 13.1 Detais of Cinica Trias This cause requires the provision of detais about ongoing cinica trias (which must be registered within 21 days of initiation of patient enroment) and the resuts of competed trias for medicines icensed for use and commerciay avaiabe in at east one country. Further information can be found in the current Joint Position on the Discosure of Cinica Tria Information via Cinica Tria Registries and Databases and the current Joint Position on the Pubication of Cinica Tria Resuts in the Scientific Literature, both at Companies must incude on the home page of their website information as to where detais of their cinica trias can be found. Detais about cinica trias must be imited to factua and non-promotiona information. Such information must not constitute promotion to heath professionas, other reevant decision makers or the pubic. Cause 13.3 Pubication of Detais and Resuts This requirement appies to non-interventiona studies competed on and after 1 May 2011 with which a UK company has had any invovement. Companies are, however, encouraged to pubish detais and resuts of such studies competed prior to that date. Cause 13.4 Other Studies Covered by Cause 13.2 Companies are encouraged to compy with Cause 13.4 for a other types of studies covered by Cause 13.2, incuding epidemioogica studies and registries and other studies that are retrospective in nature. In any case, such studies are subject to Cause 21. Cause 13.4 Approva and Supervision The approva and supervision of non-interventiona studies are deat with in Cause Cause 13.4 Date of Impementation Companies must compy with Cause 13.4 in reation to noninterventiona studies that are competed on or after 1 Juy Companies are encouraged to compy in reation to studies competed prior to that date. Cause 14 Certification 14.1 Promotiona materia must not be issued uness its fina form, to which no subsequent amendments wi be made, has been certified by two persons on behaf of the company in the manner provided for by this cause. One of the two persons must be a registered medica practitioner or a pharmacist registered in the UK or aternativey, in the case of a product for denta use ony, a UK registered dentist. The second person certifying on behaf of the company must be a senior officia of the company or an appropriatey quaified person A meetings which invove trave outside the UK must be certified in advance in a manner simiar to that provided for by Cause 14.1 uness the company s ony invovement is to support a speaker to present at the meeting The foowing must be certified in advance in a manner simiar to that provided for by Cause 14.1: educationa materia for the pubic or patients issued by companies which reates to diseases or medicines but is not intended as promotion for those medicines materia reating to working with patient organisations as described in Cause 27 and its suppementary information materia reating to joint working between the NHS and the pharmaceutica industry as described in Cause 20 and its suppementary information materia reating to patient support programmes invoving the provision to heath professionas of items to be passed on to patients as described in Cause 18.2 and its suppementary information non-promotiona materia for patients or heath professionas reating to the provision of medica and educationa goods and services, incuding reevant interna company instructions, as described in Cause 19.1 and paragraph 8 of its suppementary information The names of those nominated, together with their quaifications, sha be notified in advance to the Advertising Standards Unit, Vigiance and Risk Management of Medicines of the Medicines and Heathcare Products Reguatory Agency and to the Prescription Medicines Code of Practice Authority. The names and quaifications of designated aternative signatories must aso be given. Changes in the names of nominees must be prompty notified The certificate for promotiona materia must certify that the signatories have examined the fina form of the materia and that in their beief it is in accordance with the requirements of the reevant reguations reating to advertising and this Code, is not inconsistent with the marketing authorization and the summary of product characteristics and is a fair and truthfu presentation of the facts about the medicine. 20 CODE OF PRACTICE

22 The certificates for materia covered by Cause 14.3 above must certify that the signatories have examined the fina form of the materia and that in their beief it compies with the Code. Materia which is sti in use must be recertified at intervas of no more than two years to ensure that it continues to conform with the reevant reguations reating to advertising and the Code. The certificate for meetings invoving trave outside the UK must certify that the signatories have examined a the proposed arrangements for the meeting and that in their beief the arrangements are in accordance with the reevant reguations reating to advertising and the Code Companies sha preserve a certificates. In reation to certificates for promotiona materia, the materia in the form certified and information indicating the persons to whom it was addressed, the method of dissemination and the date of first dissemination must aso be preserved. In reation to certificates for meetings invoving trave outside the UK, detais of the programme, the venue, the reasons for using the venue, the audience, the anticipated and actua costs and the nature of the hospitaity and the ike must aso be preserved. Companies sha preserve certificates and the reevant accompanying information for not ess than three years after the fina use of the promotiona materia or the date of the meeting and produce them on request from the Medicines and Heathcare Products Reguatory Agency or the Prescription Medicines Code of Practice Authority. The certificates for materia covered by Cause 14.3 above sha be preserved for not ess that three years after the fina use of the materia and companies sha produce them on request from the Medicines and Heathcare Products Reguatory Agency or the Prescription Medicines Code of Practice Authority. Cause 14 Suppementary Information Cause 14.1 Certification An acceptabe way to compy with Cause 14.1 is for the fina proof to be certified but this is not obigatory provided that that which is certified is in its fina form to which no subsequent amendments wi be made. Companies may use vaidated eectronic signatures for certifying materia. Paper or eectronic copies of certificates and the fina form of materia etc must be preserved in order to compy with Cause When certifying materia where the fina form is to be printed companies can certify the fina eectronic version of the item to which no subsequent amendments wi be made. When such materia is printed the company must ensure that the printed materia cannot be used unti any one of the company s signatories has checked and signed the item in its fina form. In such circumstances the materia wi have two certificates and both must be preserved. A promotiona materia must be certified in this way incuding audio and audio-visua materia, promotiona materia on databases, interactive data systems and the Internet and reevant representatives briefing materias. Promotiona aids must aso be certified. Athough not stricty promotiona materia they are used for a promotiona purpose. Account shoud be taken of the fact that a non-promotiona item can be used for a promotiona purpose and therefore come within the scope of the Code. In certifying audio and audio-visua materia and promotiona materia on databases, interactive systems and the Internet, companies must ensure that a written transcript of the materia is certified incuding reproductions of any graphs, tabes and the ike that appear in it. In the event of a compaint, a copy of the written materia wi be requested. Aternativey companies may certify materia on interactive systems by means of producing an eectronic copy, for exampe on a CD Rom or data stick, if the eectronic copy is write protected and unabe to be changed. The guideines on company procedures reating to the Code which are on page 53 give further information on certification. See aso the suppementary information to Cause 3 on promotion at internationa conferences regarding the certification of such materia. Cause 14.1 Certifying Digita Materia When certifying dynamic content for websites, care must be taken to ensure the dynamic content meets the requirements of the Code both as a standaone item and within the context in which it appears. The fina form of digita materia might not be static. Cause 14.1 Suitabe Quaifications for Signatories In deciding whether a person can be a nominated signatory, account shoud be taken of product knowedge, reevant experience both within and outwith the industry, ength of service and seniority. In addition signatories must have an upto-date, detaied knowedge of the Code. Cause 14.1 Joint Ventures and Co-Promotion In a joint venture in which a third party provides a service on behaf of a number of pharmaceutica companies, the pharmaceutica companies invoved are responsibe for any activity carried out by that third party on their behaf. It foows therefore that the pharmaceutica companies invoved shoud be aware of a aspects of the service carried out on their behaf and take this into account when certifying the materia or activity invoved. Simiary if two or more pharmaceutica companies organise a joint meeting each company shoud ensure that the arrangements for the meeting are acceptabe. Under co-promotion arrangements or other arrangements where companies work together, such as joint working projects, the companies concerned can agree to have ony two fina signatories to certify on behaf of a the companies. This must a be agreed beforehand and the Medicines and Heathcare Products Reguatory Agency and the Prescription Medicines Code of Practice Authority must be informed in advance who the signatories wi be. In the event of a compaint about materia certified in this way each company invoved in the project/activity woud be responsibe under the Code. Cause 14.2 Meetings Invoving Trave Outside the UK When certifying meetings which invove trave outside the UK, the signatories shoud ensure that a the arrangements are examined, incuding the programme, the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitaity and the ike. Cause 14.3 Examination of Other Materia Other materia issued by companies which reates to medicines but which is not intended as promotiona materia for those medicines per se, such as corporate advertising, press reeases, market research materia, financia information to inform CODE OF PRACTICE 21

23 sharehoders, the Stock Exchange and the ike, and written responses from medica information departments or simiar to unsoicited enquiries from the pubic etc, shoud be examined to ensure that it does not contravene the Code or the reevant statutory requirements. Cause 14.3 Non-Interventiona Studies The examination of non-interventiona studies is deat with in Cause 25.2 and is not covered by Cause 14. Cause 14.4 Notification of Signatories The names and quaifications of signatories and changes to them shoud be notified to the Medicines and Heathcare Products Reguatory Agency by emai to Cause 14.6 Retention of Documentation Companies shoud note that the Medicines and Heathcare Products Reguatory Agency is entited to request particuars of an advertisement, incuding particuars as to the content and form of the advertisement, the method of dissemination and the date of first dissemination, and such a request is not subject to any time imit. This does not appy to the certificates themseves in respect of which the three year imit in Cause 14.6 is appicabe. Cause 15 Representatives 15.1 Representatives must be given adequate training and have sufficient scientific knowedge to enabe them to provide fu and accurate information about the medicines which they promote Representatives must at a times maintain a high standard of ethica conduct in the discharge of their duties and must compy with a reevant requirements of the Code Representatives must not empoy any inducement or subterfuge to gain an interview. No fee shoud be paid or offered for the grant of an interview Representatives must ensure that the frequency, timing and duration of cas on heath professionas and other reevant decision makers in hospitas and NHS and other organisations, together with the manner in which they are made, do not cause inconvenience. The wishes of individuas on whom representatives wish to ca and the arrangements in force at any particuar estabishment, must be observed In an interview, or when seeking an appointment for one, representatives must at the outset take reasonabe steps to ensure that they do not misead as to their identity or that of the company they represent Representatives must transmit forthwith to the scientific service referred to in Cause 25.1 any information which they receive in reation to the use of the medicines which they promote, particuary reports of adverse reactions Representatives must be paid a fixed basic saary and any addition proportiona to saes of medicines must not constitute an undue proportion of their remuneration Representatives must provide, or have avaiabe to provide if requested, a copy of the summary of product characteristics for each medicine which they are to promote Companies must prepare detaied briefing materia for medica representatives on the technica aspects of each medicine which they wi promote. A copy of such materia must be made avaiabe to the Medicines and Heathcare Products Reguatory Agency and the Prescription Medicines Code of Practice Authority on request. Briefing materia must compy with the reevant requirements of the Code and, in particuar, is subject to the certification requirements of Cause 14. Briefing materia must not advocate, either directy or indirecty, any course of action which woud be ikey to ead to a breach of the Code Companies are responsibe for the activities of their representatives if these are within the scope of their empoyment even if they are acting contrary to the instructions which they have been given. Cause 15 Suppementary Information Cause 15 Representatives A provisions in the Code reating to the need for accuracy, baance, fairness, good taste etc appy equay to ora representations as we as to printed and eectronic materia. Representatives must not make caims or comparisons which are in any way inaccurate, miseading, disparaging, in poor taste etc, or which are outside the terms of the marketing authorization for the medicine or are inconsistent with the summary or product characteristics. Indications for which the medicine does not have a marketing authorization must not be promoted. Attention is drawn to the provisions of Cause 9.9 which prohibit the use of the teephone, text messages, emai, teemessages and facsimie etc for promotiona purposes, except with the prior permission of the recipient. Cause 15 Contract Representatives Companies empoying or using contract representatives are responsibe for their conduct and must ensure that they compy with the provisions of this and a other reevant causes in the Code, and in particuar the training requirements under Causes 15.1, 16.1 and Cause 15.3 Hospitaity and Payments for Meetings Attention is drawn to the requirements of Causes 18 and 22 which prohibit the provision of any financia inducement for the purposes of saes promotion and require that any hospitaity provided is secondary to the purpose of a meeting, is not out of proportion to the occasion and does not extend beyond members of the heath professions or other reevant decision makers. 22 CODE OF PRACTICE

24 Meetings organised for groups of doctors, other heath professionas and/or other reevant decision makers which are whoy or mainy of a socia or sporting nature are unacceptabe. Representatives organising meetings are permitted to provide appropriate hospitaity and/or to meet any reasonabe, actua costs which may have been incurred. For exampe, if the refreshments have been organised and paid for by a medica practice the cost may be reimbursed as ong as it is reasonabe in reation to what was provided and the refreshments themseves were appropriate for the occasion. Donations in ieu of hospitaity are unacceptabe as they are inducements for the purpose of hoding a meeting. If hospitaity is not required at a meeting there is no obigation or right to provide some benefit of an equivaent vaue. Cause 15.3 Donations to Charities Donations to charities in return for representatives gaining interviews are prohibited under Cause Cause 15.3 Items Deivered by Representatives Repy paid cards which refer to representatives deivering items to heath professionas or other reevant decision makers shoud expain that there is no obigation to grant the representative an interview when the items are deivered. This is to avoid the impression that there is such an obigation, which woud be contrary to Cause 15.3 which prohibits the use of any inducement or subterfuge to gain an interview. Cause 15.3 Heath Professionas Codes of Conduct The Genera Medica Counci is the reguatory body for doctors and is responsibe for giving guidance on standards of professiona conduct and on medica ethics. In its guidance, the GMC advises doctors that You must not aow any interests you have to affect the way you prescribe for, treat, refer or commission services for patients and You must not ask for or accept from patients, coeagues or others any inducement, gift or hospitaity that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients. You must not offer these inducements. The Genera Pharmaceutica Counci is the reguatory body for pharmacists and pharmacy technicians. The Counci s Standards of conduct, ethics and performance state Do not ask for or accept gifts, rewards or hospitaity that may affect, or be seen to affect, your professiona judgement. The Code of the Nursing & Midwifery Counci, Standards of conduct, performance and ethics for nurses and midwives, states You must not abuse your privieged position for your own ends and You must ensure that your professiona judgement is not infuenced by any commercia considerations. Cause 15.4 Frequency and Manner of Cas on Doctors and Other Prescribers The number of cas made on a doctor or other prescriber and the intervas between successive visits are reevant to the determination of frequency. Companies shoud arrange that intervas between visits do not cause inconvenience. The number of cas made on a doctor or other prescriber by a representative each year shoud not normay exceed three on average. This does not incude the foowing which may be additiona to those three visits: attendance at group meetings, incuding audio-visua presentations and the ike a visit which is requested by a doctor or other prescriber or a ca which is made in order to respond to a specific enquiry a visit to foow up a report of an adverse reaction. Representatives must aways endeavour to treat prescribers time with respect and give them no cause to beieve that their time might have been wasted. If for any unavoidabe reasons, an appointment cannot be kept, the ongest possibe notice must be given. When briefing representatives companies shoud distinguish ceary between expected ca rates and expected contact rates. Contacts incude those at group meetings, visits requested by doctors or other prescribers, visits in response to specific enquiries and visits to foow up adverse reaction reports. Targets must be reaistic and not such that representatives breach the Code in order to meet them. Cause 15.8 Provision of Summary of Product Characteristics The requirement to provide a copy of the summary of product characteristics can be met by the provision of an eectronic copy if the recipient agrees. If discussion on a medicine is initiated by the person or persons on whom a representative cas, the representative is not obiged to have avaiabe the information on that medicine referred to in this cause. Cause 15.9 Briefing Materia The detaied briefing materia referred to in this cause consists of both the training materia used to instruct medica representatives about a medicine and the instructions given to them as to how the product shoud be promoted. Cause 16 Training 16.1 A reevant personne incuding representatives and members of staff, and others retained by way of contract, concerned in any way with the preparation or approva of materia or activities covered by the Code must be fuy conversant with the Code and the reevant aws and reguations A personne (and others retained by way of contract) must be fuy conversant with pharmacovigiance requirements reevant to their work and this must be documented Representatives must take an appropriate examination within their first year of empoyment as a representative and must pass it within two years of starting such empoyment. To be acceptabe, an examination must have been accredited to at east Leve 3 by an externa awarding body recognised by Ofqua. CODE OF PRACTICE 23

25 An appropriate examination for medica representatives is one that requires a broad understanding of body systems, diseases and treatments, the deveopment of new medicines and the structure and function of the NHS and of the pharmaceutica industry. Such an examination must be a Dipoma (at east 37 credits or equivaent earning hours). An appropriate examination for generic saes representatives is one that requires a broad understanding of body systems, the structure and function of the NHS and of the pharmaceutica industry. Such an examination must be a Certificate (at east 13 credits or equivaent earning hours). An appropriate examination can be either the reevant ABPI examination (for medica or generic saes representatives) or an examination of at east the same standard as the ABPI examinations and covering simiar content and earning materia as the corresponding ABPI examination Detais of the numbers of representatives who have passed an examination, together with the examination status of others, must be provided to the Prescription Medicines Code of Practice Authority on request. Cause 16 Suppementary Information Cause 16.1 Scope of the Code The materias/activities covered by the Code incude promotiona materias and activities isted in Cause 1.1, information provided to heath professionas and other reevant decision makers and information provided to the pubic, patients and patient organisations. Cause 16.1 Training Extensive in house training on the Code is carried out by companies and by the Prescription Medicines Code of Practice Authority. In addition, the Authority runs seminars on the Code which are open to a companies and personne from advertising agencies, pubic reations agencies and the ike which act for the pharmaceutica industry. Detais of these seminars can be obtained from the Authority. Cause 16.3 Examinations The ABPI offers two examinations and further detais can be obtained from the ABPI. Examinations may aso be offered by other providers. A company using an examination provider other than the ABPI must be abe to demonstrate that its examinations are at east equivaent to those offered by the ABPI. The syabus studied shoud be mapped to and meet the requirements in the pubished ABPI standards. The assessment must be under invigiated examination conditions. The ABPI Medica Representatives Examination is appropriate for representatives whose duties comprise or incude one or both of: caing upon doctors and/or dentists and/or other prescribers the promotion of medicines on the basis, inter aia, of their particuar therapeutic properties. The ABPI Generic Saes Representatives Examination is appropriate for representatives who promote medicines primariy on the basis of price, quaity and avaiabiity to those who do not prescribe medicines. The ABPI examinations for medica representatives and generic saes representatives are based on materia pubished by the ABPI. Persons who have passed the ABPI Medica Representatives Examination or simiar whose duties change to those specified for generic saes representatives do not need to take another examination. However, persons who have passed the ABPI Generic Saes Representatives Examination or simiar whose duties change to those specified for medica saes representatives must take an appropriate examination within one year of their change of duties and pass it within two years. Cause 16.3 Introduction of Accredited Examinations Representatives commencing such empoyment on or after 1 October 2014 must take an accredited examination. It is recommended that representatives commencing such empoyment on or after 1 January 2014 but on or before 30 September 2014 aso take an accredited examination. The ABPI wi offer accredited examinations by January 2014 and wi cease to offer its unaccredited examinations on 31 December A candidate who has passed part of an unaccredited ABPI examination wi have to compete that examination by 31 December 2015 or transfer to an accredited examination. The imitations on time within which representatives must pass an examination, which are set out in Cause 16.3 and its suppementary information, must be borne in mind. A candidate who has taken part of an ABPI examination who wishes to transfer to a new provider wi have to take the whoe of the new provider s examination. Simiary, a candidate who has taken part of an aternative provider s examination who wishes to transfer to an ABPI examination wi have to take the whoe of that examination. This wi not appy if it can be demonstrated that the units aready passed are equivaent to those of the new provider whether that is an ABPI examination or an aternative provider s examination. Cause 16.3 Information from Examination Provider A company must take steps to ensure that its examination provider woud respond to requests for information from the Authority. Cause 16.3 Time Aowed to Pass an Examination Prior to passing an appropriate examination, representatives may be engaged in such empoyment for no more than two years, whether continuous or otherwise and irrespective of whether with one company or with more than one company. A representative cannot, for exampe, work eighteen months with one company and eighteen months with another and so on, thus avoiding an examination. Maternity or paternity eave does not count towards the specified time periods. In the event of extenuating circumstances, such as proonged iness or no or inadequate opportunity to take an appropriate examination, the Director of the Prescription Medicines Code of Practice Authority may agree to the continued empoyment of a person as a representative past the end of the two year period, subject to the representative passing an appropriate examination within a reasonabe time. Simiary, in the event of faiure to take an appropriate examination within the first year, the Director may agree to an extension, subject to the representative taking an examination within a reasonabe time. 24 CODE OF PRACTICE

26 An appication for an extension shoud be made on a form avaiabe from the Prescription Medicines Code of Practice Authority. It shoud preferaby be made by the company rather than the representative. Service as a representative prior to 1 January 2006 by persons who were exempt from taking the appropriate examination by virtue of Cause 16.4 of the 2003 edition of the Code does not count towards the two year imit on empoyment as a representative prior to passing the appropriate examination. Cause 17 Provision of Medicines and Sampes 17.1 Sampes of a product may be provided ony to a heath professiona quaified to prescribe that product. They must not be provided to other reevant decsion makers No more than four sampes of a particuar medicine may be provided to an individua heath professiona during the course of a year. Sampes of a particuar medicine may be provided to a heath professiona for no onger than two years after that heath professiona first requests sampes of it. Notwithstanding the above, when a new medicine is marketed which is an extension of an existing product, sampes of that new medicine can be provided as above. A new medicine in this context is a product for which a new marketing authorization has been granted, either foowing the initia appication or foowing an extension appication for a new indication that incudes new strengths and/or dosage forms. Extension of a marketing authorization to incude additiona strengths and/or dosage forms for existing indications or to incude additiona pack sizes is not regarded as eading to new medicines Sampes may ony be suppied in response to written requests which have been signed and dated. An eectronic signature is acceptabe A sampe of a medicine must be no arger than the smaest presentation of the medicine on the market in the UK Each sampe must be marked free medica sampe not for resae or words to that effect and must be accompanied by a copy of the summary of product characteristics The provision of sampes is not permitted for any medicine which contains a substance isted in any of Schedues I, II or IV to the Narcotic Drugs Convention (where the medicine is not a preparation isted in Schedue III to that Convention) or a substance isted in any of Schedues I to IV to the Psychotropic Substances Convention (where the medicine is not a preparation which may be exempted from measures of contro in accordance with Paragraphs 2 and 3 of Artice 3 of that Convention) Sampes distributed by representatives must be handed direct to the heath professionas requesting them or persons authorized to receive them on their behaf The provision of medicines and sampes in hospitas must compy with individua hospita requirements Companies must have adequate systems of contro and accountabiity for sampes which they distribute and for a medicines handed by representatives. Systems must ceary estabish, for each heath professiona, the number of sampes suppied in accordance with Cause Medicines which are sent by post must be packed so as to be reasonaby secure against being opened by young chidren. No unsoicited medicine must be sent through the post Medicines may not be sod or suppied to members of the pubic for promotiona purposes Sampes must not be provided simpy as an inducement to prescribe, suppy, administer, recommend, buy or se any medicine. Sampes must not be given for the soe purpose of treating patients. Cause 17 Suppementary Information Cause 17 Definition of Sampe A sampe is a sma suppy of a medicine provided to heath professionas so that they may famiiarise themseves with it and acquire experience in deaing with it. A sampe of a medicine may be provided ony to a heath professiona quaified to prescribe that particuar medicine. A sma sampe which is provided ony for identification or simiar purposes and which is not intended to be used in treatment may be provided to any heath professiona but is otherwise subject to the requirements of Cause 17. Titration packs, free goods and bonus stock provided to pharmacists and others are not sampes. This is because they are not for the purposes described above. Titration packs are packs containing various strengths of a medicine for the purpose of estabishing a patient on an effective dose. The suppy of a product which is not a medicine because it does not contain the active ingredient normay present is not regarded as the suppy of a sampe. Cause 17 Starter Packs The provision of starter packs is not permitted. Starter packs were sma packs designed to provide sufficient medicine for a primary care prescriber to initiate treatment in such circumstances as a ca out in the night. Cause 17.3 Sampe Requests This cause does not precude the provision of a preprinted sampe request form bearing the name of the product for signing and dating by the appicant. CODE OF PRACTICE 25

27 A signed and dated written requests for sampes shoud be retained for not ess than one year. Cause 17.9 Contro and Accountabiity Companies shoud ensure that their systems of contro and accountabiity reating to medicines hed by representatives cover such matters as the security of deivery to them, the security of medicines hed by them, the audit of stocks hed by them, incuding expiry dates, and the return to the companies of medicines no onger to be hed by representatives. Cause 18 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 18.1 No gift, pecuniary advantage or benefit may be suppied, offered or promised to members of the heath professions or to other reevant decision makers in connection with the promotion of medicines or as an inducement to prescribe, suppy, administer, recommend, buy or se any medicine, subject to the provisions of Causes 18.2 and Heath professionas may be provided with items which are to be passed on to patients and which are part of a forma patient support programme, the detais of which have been appropriatey documented and certified in advance as required by Cause The items provided must be inexpensive and directy benefit patient care. They may bear the name of the company providing them. They must not be given out from exhibition stands. They must not be given to administrative staff uness they are to be passed on to a heath professiona Heath professionas and other reevant decision makers attending company organised scientific meetings and conferences, promotiona meetings and the ike may be provided with inexpensive notebooks, pens and pencis for use at those meetings. They must not bear the name of any medicine or any information about medicines but may bear the name of the company providing them. If pens and pads are provided in conference bags at third party organised meetings then these must not incude the names of the donor companies, the name of any medicine or any information about medicines. Cause 18 Suppementary Information Cause 18.1 Heath Professionas Codes of Conduct The Genera Medica Counci is the reguatory body for doctors and is responsibe for giving guidance on standards of professiona conduct and on medica ethics. In its guidance, the GMC advises doctors that You must not aow any interests you have to affect the way you prescribe for, treat, refer or commission services for patients and You must not ask for or accept from patients, coeagues or others any inducement, gift or hospitaity that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients. You must not offer these inducements. The Genera Pharmaceutica Counci is the reguatory body for pharmacists and pharmacy technicians. The Counci s Standards of conduct, ethics and performance state Do not ask for or accept gifts, rewards or hospitaity that may affect, or be seen to affect, your professiona judgement. The Code of the Nursing & Midwifery Counci, Standards of conduct, performance and ethics for nurses and midwives, states You must not abuse your privieged position for your own ends and You must ensure that your professiona judgement is not infuenced by any commercia considerations. Cause 18.1 Terms of Trade Measures or trade practices reating to prices, margins and discounts which were in reguar use by a significant proportion of the pharmaceutica industry on 1 January 1993 are outside the scope of the Code (see Cause 1.2) and are excuded from the provisions of this cause. Other trade practices are subject to the Code. The terms prices, margins and discounts are primariy financia terms. Schemes which enabe heath professionas to obtain persona benefits, for exampe gift vouchers for high street stores, in reation to the purchase of medicines are unacceptabe even if they are presented as aternatives to financia discounts. Cause 18.1 Package Deas Cause 18.1 does not prevent the offer of package deas which are commercia arrangements whereby the purchase of a particuar medicine is inked to the provision of certain associated benefits as part of the purchase price, such as apparatus for administration, the provision of training on its use or the services of a nurse to administer it. The transaction as a whoe must be fair and reasonabe and the associated benefits must be reevant to the medicine invoved. Cause 18.1 Outcome or Risk Sharing Agreements Cause 18.1 does not precude the use of outcome or risk sharing agreements where a fu or partia refund of the price paid for a medicine, or some other form of recompense, is due if the outcome of the use of the medicine in a patient fais to meet certain criteria. That is to say its therapeutic effect does not meet expectations. Cear criteria as to when a refund or other recompense woud be due must be setted in advance and set out in the agreement. Any refund or recompense must aways go to the reevant NHS or other organisation and never to individua heath professionas or practices etc. Cause 18.1 Patient Access Schemes Patient access schemes are acceptabe in principe under the Code but they must be carried out in conformity with its requirements. The 2014 Pharmaceutica Price Reguation Scheme describes patient access schemes as schemes proposed by a pharmaceutica company and agreed with the Department of Heath (with input from the Nationa Institute for Heath and Care Exceence) in order to improve the cost-effectiveness of 26 CODE OF PRACTICE

28 a medicine and enabe patients to receive access to cost-effective innovative medicines. Corresponding arrangements appy in the devoved nations. Cause 18.1 Donations to Charities Donations to charities made by companies in return for heath professionas attendance at company stands at meetings are not unacceptabe under this cause provided that the eve of donation for each individua is modest, the money is for a reputabe charity and any action required of the heath professiona is not inappropriate. Any donation to a charity must not constitute a payment that woud otherwise be unacceptabe under the Code. For exampe, it woud not be acceptabe for a representative to pay into a practice equipment fund set up as a charity as this woud be a financia inducement prohibited under Cause Donations to charities in return for representatives gaining interviews are aso prohibited under Cause Any offer by a company of a donation to a charity which is conditiona upon some action by a heath professiona must not pace undue pressure on the heath professiona to fufi that condition. At a times the provisions of Causes 2 and 9.1 must be kept in mind. Cause 18.1 Payments to Individuas Any payment to an individua for an activity that is rued in breach of Cause 12.2 and/or Cause 23 is ikey to be viewed as an unacceptabe payment and thus in breach of Cause Cause 18.1 Long term or Permanent Loan The requirements of Cause 18.1 cannot be avoided by providing heath professionas or practices etc with items on ong term or permanent oan. Such items wi be regarded as gifts and subject to the requirements of this cause. Cause 18.1 Competitions and Quizzes The use of competitions, quizzes and suchike, and the giving of prizes, are unacceptabe methods of promotion. This does not precude the use at promotiona meetings of quizzes which are intended to gauge attendees knowedge of the subject matter of the meetings, provided that such quizzes are non-promotiona in nature and are bona fide tests of ski that recognise the professiona standing of the audience and no prizes are offered. To be acceptabe a quiz must form part of the meeting s forma proceedings. Exhibition stands must not be incuded in any way in the conduct of a quiz. Cause 18.1 Promotiona Aids A promotiona aid is defined as a non-monetary gift made for a promotiona purpose. Promotiona aids may be given to heath professionas and other reevant decision makers ony in accordance with Cause Heath professionas may, however, be provided with items which are to be passed on to patients in accordance with Cause Items to be passed on to patients may bear the name of a medicine and/or information about medicines ony if such detai is essentia for the proper use of the item by patients. Items for the persona benefit of heath professionas or other reevant decision makers must not be offered or provided. Gifts such as coffee mugs, stationery, computer accessories, diaries, caendars and the ike are not acceptabe. Gifts of items for use with patients in the cinic, surgery or treatment room etc, such as surgica goves, nai brushes, tongue depressors, tissues and the ike, are aso not acceptabe. Items such as toys and puzzes intended for chidren to pay with whie waiting must not be provided. Gifts of items for use in the home or car are unacceptabe. Pharmaceutica companies cannot give diaries and desk pads etc to heath professionas and appropriate administrative staff but there is nothing to prevent them being given by other parties which are not pharmaceutica companies. Advertisements for prescription medicines must not appear on any items, such as diaries and desk pads, which pharmaceutica companies coud not themseves give. Literature such as eafets, bookets and textbooks about medicines and their uses, which is intended for patients, can be provided to heath professionas for them to pass on. They are not considered to be promotiona aids but they must compy with reevant requirements of the Code, in particuar Cause 26 and its suppementary information. A story-book for young patients about a product or a disease coud be provided for reevant patients. Cause 18.1 DVDs Cause 18.1 does not precude the provision to heath professionas and other reevant decision makers of inexpensive DVDs etc which bear educationa or promotiona materia compiant with the Code, provided that they cannot be used by the recipient to store other data. Cause 18.1 Memory Sticks Cause 18.1 does not precude the provision to heath professionas and other reevant decision makers of inexpensive memory sticks which bear educationa or promotiona materia compiant with the Code, provided that their storage capacity is commensurate with the amount of data to be stored. Cause 18.1 Textbooks Textbooks must not be given to heath professionas as promotiona aids. In appropriate circumstances independenty produced medica/educationa pubications such as textbooks coud be given for heath professionas to use in accordance with Cause 19.1 Medica and Educationa Goods and Services but they must not be given to individuas. Cause 18.2 Patient Support Items Athough items which are to be passed on to patients may not be given out from exhibition stands, they may be exhibited and demonstrated on stands and requests for them accepted for ater deivery. Patient support items may be provided to heath professionas by representatives during the course of a promotiona ca and representatives may deiver such items when they are requested by heath professionas, for exampe on repy paid cards. Exampes of items which might be acceptabe incude a peak fow meter as part of a scheme for patients to reguary record readings or a pedometer as part of a scheme to encourage exercise, perhaps for obese patients. Provided that they have been appropriatey documented and certified in advance as required by Cause 14.3, in imited circumstances patient support items may be made avaiabe for the use of heath professionas even though they are not to be passed on to patients for them to keep. This is where their purpose is to aow patients to gain experience in using their medicines whist under the supervision of a heath professiona. Exampes incude inhaation devices (with no active ingredient) and devices intended to assist patients to earn how to sef-inject. An inexpensive item means one that has cost the donor company no more than 6, excuding VAT. The perceived vaue to the heath professiona and the patient must be simiar. CODE OF PRACTICE 27

29 Cause 18.2 Items Given to Patients Items which may be made avaiabe to patients, for exampe by competing a request card encosed with a medicine, shoud be inexpensive and reated to either the condition under treatment or genera heath. Care must be taken that any such activity meets a the requirements of the Code and in particuar Cause 26. No item for use by patients must be given for the purpose of encouraging patients to request a particuar medicine. Companies cannot run or sponsor competitions or quizzes for patients if prizes are offered to individuas. A competition for patients where the prizes were heath reated and were given to a cinic or simiar might be acceptabe. Cause 18.3 Notebooks, Pens and Pencis Notebooks, pens and pencis are the ony items that can be provided to heath professionas and other reevant decision makers for them to keep and then ony at bona fide meetings. They cannot be provided, for exampe, by representatives when caing upon heath professionas. No individua attendee shoud receive more than one notebook and one pen or penci. The tota cost to the donor company of a such items provided to an individua person attending a meeting must not exceed 6, excuding VAT. The perceived vaue to the recipient must be simiar. Notebooks, pens and pencis must not be given out from exhibition stands. Notebooks, pens and pencis provided at company organised meetings may bear the name of the donor company but not the name of any medicine or any information about medicines. Notebooks, pens and pencis incuded in conference bags at third party organised meetings may not bear the names of the donor companies or the name of any medicine or any information about medicines. Cause 19 Medica and Educationa Goods and Services 19.1 Medica and educationa goods and services which enhance patient care, or benefit the NHS and maintain patient care, can be provided subject to the provisions of Cause They must not be provided to individuas for their persona benefit. Medica and educationa goods and services must not bear the name of any medicine but may bear the name of the company providing them The provision of medica and educationa goods and services in the form of donations, grants and benefits in kind to institutions, organisations or associations that are comprised of heath professionas and/or that provide heathcare or conduct research are ony aowed if: they compy with Cause 19.1 or are made for the purpose of supporting research they are documented and kept on record by the company they do not constitute an inducement to prescribe, suppy, administer, recommend, buy or se any medicine detais are pubicy discosed as donations, grants or benefits in kind or as research and deveopment transfers of vaue. Cause 19 Suppementary Information Cause 19.1 Medica and Educationa Goods and Services Causes 18.1 and 19.1 do not prevent the provision of medica and educationa goods and services. In order to compy with the Code such goods and services must be in the interests of patients or benefit the NHS whist maintaining patient care. They must not be provided to individuas for their persona benefit. The requirement in Cause 19.1 that medica and educationa goods must not bear the name of any medicine does not appy where the goods invoved consist of independenty produced textbooks or journas which incude as part of their texts the names of medicines. Medica and educationa goods and services may bear a corporate name. The invovement of a pharmaceutica company in such activities must be made cear to reevant heath professionas and/or other reevant decision makers receiving the service. In addition the invovement of a pharmaceutica company in therapy review services shoud be made cear to patients. However, if there are no materias for patients this woud be a matter for the reevant heath professiona. If there are materias for patients the requirements for decaration of sponsorship set out in Cause 9.10 woud appy. The foowing guidance is intended to assist companies in reation to medica and educationa goods and services. 1(i) The roe of medica/generic representatives in reation to the provision of goods and services suppied in accordance with Causes 18.1 and 19.1 needs to be in accordance with the principes set out beow. In this context companies shoud consider using staff other than medica/generic representatives. (ii) If medica/generic representatives provide, deiver or demonstrate medica and educationa goods and services then this must not be inked in any way to the promotion of products. In order to compy with this stipuation the representative must not carry out both activities at the same visit. Representatives may introduce a service by means of a brief description and/or deivering materias but may not instigate a detaied discussion about the service at the same time as a ca at which products are promoted. If, during a promotiona visit by a representative, a change in medication to one of the company s products is agreed, the representative may not then offer a therapy review service to faciitate the change as this woud be seen as a way for the company to ensure that the agreed change woud in fact be made. (iii) The acceptabiity of the roe of medica/generic 28 CODE OF PRACTICE

30 representatives wi depend on the nature of the goods and services provided and the method of provision. (iv) The nature of the service provider, the person associated with the provision of medica and educationa goods and services, is important ie is the service provider a medica/generic representative or is the service provider some other appropriatey quaified person, such as a sponsored registered nurse? If the goods and services require patient contact, for exampe either directy or by identification of patients from patient records and the ike, then medica/generic representatives must not be invoved. Ony an appropriatey quaified person, for exampe a sponsored registered nurse, not empoyed as a medica/generic representative, may undertake activities reating to patient contact and/or patient identification. Medica/generic representatives coud provide administrative support in reation to the provision of a screening service, but must not be present during the actua screening and must not discuss or hep interpret individua cinica findings. (v) Neither the company nor its medica/generic representatives may be given access to data/records that coud identify, or coud be inked to, particuar patients. (vi) Sponsored heath professionas shoud not be invoved in the promotion of specific products. Registered nurses, midwives and heath visitors are required to compy with the Nursing & Midwifery Counci Code - Standards of conduct, performance and ethics for nurses and midwives. 2 The remuneration of those not empoyed as medica/generic representatives but who are sponsored or empoyed as service providers in reation to the provision of medica and educationa goods and services must not be inked to saes in any particuar territory or pace or to saes of a specific product or products and, in particuar, may not incude a bonus scheme inked to such saes. Bonus schemes inked to a company s overa nationa performance, or to the eve of service provided, may be acceptabe. 3 Companies must ensure that patient confidentiaity is maintained at a times and that data protection egisation is compied with. 4 Service providers must operate to detaied written instructions provided by the company. These shoud be simiar to the briefing materia for representatives as referred to in Cause The written instructions shoud set out the roe of the service provider and shoud cover patient confidentiaity issues. Instructions on how the recipients are to be informed etc shoud be incuded. The written instructions must not advocate, either directy or indirecty, any course of action which woud be ikey to ead to a breach of the Code. 5 Service providers must abide by the principe set out in Cause 15.5 that in an interview, or when seeking an appointment, reasonabe steps must be taken to ensure that they do not misead as to their identity or that of the company they represent. 6 A recipient of a service must be provided with a written protoco to avoid misunderstandings as to what the recipient has agreed. The identity of the sponsoring pharmaceutica company must be given. For exampe, a genera practitioner aowing a sponsored registered nurse access to patient records shoud be informed in writing of any data to be extracted and the use to which those data wi be put. 7 Any materia designed for use in reation to the provision of medica and educationa goods and services must be nonpromotiona. It is not acceptabe for such materias to promote the prescription, suppy, sae or administration of the sponsoring company s medicines. Nor is it acceptabe for materias to criticise competitor products as this might be seen as promotiona. A materias must identify the sponsoring pharmaceutica company. 8 Materia reating to the provision of medica and educationa goods and services, such as interna instructions, externa instructions, the written protoco for recipients and other materia, incuding materia reating to therapy reviews, etc, must be certified by the Code of Practice signatories within companies to ensure that the requirements of the Code are met as required by Cause A copy of the materias must be made avaiabe to the Prescription Medicines Code of Practice Authority on request. 9 Companies are recommended to inform reevant NHS or other organisations of their activities where appropriate. This is particuary recommended where companies are proposing to provide medica and educationa goods and services which woud have budgetary impications for the parties invoved. For exampe the provision of a screening service for a imited period might mean that funds woud have to be found in the future when company sponsorship stopped. Another exampe might be the provision of diagnostic or aboratory services and the ike, which the reevant organisation woud normay be expected to provide. Cause 19.1 Switch and Therapy Review Programmes Causes 18.1 and 19.1 prohibit switch services paid for or faciitated directy or indirecty by a pharmaceutica company whereby a patient s medicine is simpy changed to another. For exampe it woud be unacceptabe if patients on medicine A were changed to medicine B, without any cinica assessment, at the expense of a pharmaceutica company promoting either or both medicines. It woud be acceptabe for a company to promote a simpe switch from one product to another but not to assist a heath professiona in impementing that switch even if assistance was by means of a third party such as a sponsored nurse or simiar. Such arrangements are seen as companies in effect paying for prescriptions and are unacceptabe. A therapeutic review is different to a switch service. A therapeutic review which aims to ensure that patients receive optima treatment foowing a cinica assessment is a egitimate activity for a pharmaceutica company to support and/or assist. The resut of such cinica assessments might require, among other things, possibe changes of treatment incuding changes of dose or medicine or cessation of treatment. A genuine therapeutic review shoud incude a comprehensive range of reevant treatment choices, incuding non-medicina choices, for the heath professiona and shoud not be imited to the medicines of the sponsoring pharmaceutica company. The arrangements for therapeutic review must enhance patient care, or benefit the NHS and maintain patient care, and must otherwise be in accordance with Cause 19.1 and the suppementary information on the provision of medica and educationa goods and services. The decision to change or commence treatment must be made for each individua patient by the prescriber and every decision to change an individua patient s treatment must be documented with evidence that it was made on rationa grounds. Cause 19.1 Discosure Transfers of vaue in reation to medica or educationa goods and services must be pubicy discosed in reation to transfers CODE OF PRACTICE 29

31 of vaue made in 2015 and each caendar year thereafter, giving in each case the financia amount or vaue and the name of the recipient. Discosure must be carried out in accordance with Cause 24. Cause 19.2 Donations, Grants and Benefits in Kind Donations and grants to individua heath professionas are not covered by this cause. Company sponsorship of heath professionas to attend events is covered by Cause 22. Detais of each grant, donation or benefit in kind (transfer of vaue) must be pubicy discosed, giving in each case the financia amount or vaue and the name of the recipient institution, organisation or association. Companies are aso encouraged to ask recipients to make such funding pubic. Fees and agreed expenses shoud be discosed separatey. The information required by Cause 19.2 must be pubicy discosed in respect of donations, grants and benefits in kind made in 2015 and each caendar year thereafter. Discosure must be carried out in accordance with Cause 24. Discosure for Caendar Years 2013 and 2014 For discosures in reation to donations and grants made in caendar years 2013 and 2014, the requirements and procedures in Cause 18.6 and its suppementary information in the Second 2012 Edition of the Code continue to appy. Cause 20 Joint Working Joint working between one or more pharmaceutica companies and the NHS and others is acceptabe provided that this is carried out in a manner compatibe with the Code. Joint working must aways benefit patients. A forma written agreement must be in pace and an executive summary of the joint working agreement must be made pubicy avaiabe before arrangements are impemented. Transfers of vaue made by companies in connection with joint working must be pubicy discosed. Cause 20 Suppementary Information Cause 20 Joint Working The Department of Heath defines joint working between the NHS and the pharmaceutica industry as situations 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. Each party must make a significant contribution and the outcomes must be measured. Treatments must be in ine with nationay accepted cinica guidance where such exists. Joint working between the pharmaceutica industry and the NHS must be conducted in an open and transparent manner. Joint working must be for the benefit of patients but it is expected that the arrangements wi aso benefit the NHS and the pharmaceutica company or companies invoved. Joint working differs from the situation where pharmaceutica companies simpy provide funds for a specific event or programme. The Department of Heath has issued Best practice guidance on joint working between the NHS and pharmaceutica industry and other reevant commercia organisations. The Department of Heath and the ABPI have jointy issued Moving beyond sponsorship: interactive tookit for joint working between the NHS and the pharmaceutica industry. The ABPI has produced guidance notes on joint working between pharmaceutica companies and the NHS and others for the benefit of patients. The ABPI Guidance refers to the requirements of the Code but goes we beyond them. When considering joint working, companies shoud take account of the guidance which has been issued by the ABPI and the Department of Heath. Joint working is acceptabe in principe provided that it is carried out in conformity with the Code. In particuar, it must not constitute an inducement to heath professionas or other reevant decision makers to prescribe, suppy, recommend, buy or se any medicine. It must therefore aways be ensured that any and a of the benefits of joint working which are due to the NHS, go not to individuas or practices but to an NHS or other organisation. A joint working agreement can be based on the use of a particuar medicine of a company party to the agreement, but ony if the requirements beow are compied with and ony if the parties have satisfied themseves that the use of the medicine wi enhance patient care. Goods and services provided by the company as part of the joint working agreement must be reevant to the medicines invoved and the agreement as a whoe must be fair and reasonabe. Any goods and services provided by the company must themseves contribute to patient care. The written agreement must cover the foowing points: the name of the joint working project, the parties to the agreement, the date and the term of the agreement the expected benefits for patients, the NHS and the pharmaceutica company; patient benefits shoud aways be stated first and patient outcomes shoud be measured an outine of the financia arrangements the roes and responsibiities of the NHS and the pharmaceutica company and how the success of the project wi be measured, when and by whom; a aspects of input shoud be incuded the panned pubication of any data or outcomes if a pharmaceutica company enters into a joint working agreement on the basis that its product is aready incuded in an appropriate pace on the oca formuary, a cear reference to this shoud be incuded in the joint working agreement so that a the parties are cear as to what has been agreed contingency arrangements to cover possibe unforeseen circumstances such as changes to summaries of product characteristics and updated cinica guidance; agreements shoud incude a dispute resoution cause and disengagement/exit criteria incuding an acknowedgement by the parties that the project might need to be amended or stopped if a breach of the Code is rued 30 CODE OF PRACTICE

32 pubication by the company of an executive summary of the joint working agreement, for exampe on a ceary defined website or section of a website, such as on the company s or companies website; the NHS organisation shoud aso be encouraged to pubish this. The requirement to make the executive summary pubic appies to joint working projects started on or after 1 May 2011 or ongoing on that date. Attention is drawn to the certification requirements set out in Cause 14.3 which appy to materia reating to joint working incuding the joint working agreement, the project initiation documentation and the executive summary of the joint working agreement. Ony the fina documents etc for any joint working project need be certified. A documents etc used during the deveopment of the project shoud be of the same standard as certified materia but there is no requirement to certify such materias. Cause 19.2 is reevant to a joint working agreement between a pharmaceutica company and the NHS which does not invove the use and purchase of any of the company s medicines. Athough the ABPI Guidance is aimed principay at joint working between pharmaceutica companies and the NHS, it Cause 21 Reationships and Contracts with Certain Organisations Contracts between companies and institutions, organisations or associations of heath professionas under which such institutions, organisations or associations provide any type of services on behaf of companies (or any other type of funding by the company not otherwise covered by the Code) are ony aowed if such services (or other funding): compy with Cause 19.1 or are provided for the purpose of supporting research do not constitute an inducement to prescribe, suppy, administer, recommend, buy or se any medicine. Cause 22 Meetings, Hospitaity and Sponsorship 22.1 Companies must not provide hospitaity to members of the heath professions and other reevant decision makers except in association with scientific meetings, promotiona meetings, scientific congresses and other such meetings, and training. Meetings must be hed in appropriate venues conducive to the main purpose of the event. Hospitaity must be stricty imited to the main purpose of the event and must be secondary to the purpose of the meeting ie subsistence ony. The eve of subsistence offered must be appropriate and not out of proportion to the occasion. The costs invoved must not exceed that eve which the recipients woud normay adopt when paying for themseves. It must not extend beyond members of the heath professions or other reevant decision makers. aso covers joint working conducted though third party service providers and/or with suppiers of private heathcare. More detai as to the requirements for joint working is provided in the ABPI Guidance which shoud be consuted when joint working is contempated. Joint working shoud be distinguished from straightforward saes where medicines are simpy sod and there are no accompanying goods and services etc and from package deas and outcome or risk sharing agreements as defined in the suppementary information to Cause Cause 20 Discosure The information required by Cause 20 as to transfers of vaue must be pubicy discosed in reation to transfers of vaue made in 2015 and each caendar year thereafter, giving in each case the financia amount or vaue and the name of the recipient. Companies must ensure that the amount spent on joint working projects is made pubic irrespective of whether the vaue is transferred to a heathcare organisation or some other funding mode is used. Discosure must be carried out in accordance with Cause 24. Pharmaceutica companies must pubicy discose detais of transfers of vaue made to such institutions, organisations or associations. Cause 21 Suppementary Information Cause 21 Discosure The information required by Cause 21 must be pubicy discosed in reation to transfers of vaue made in 2015 and each caendar year thereafter, giving in each case the financia amount or vaue and the name of the recipient institution, organisation or association. Fees and agreed expenses shoud be discosed separatey. Discosure must be carried out in accordance with Cause The cost of a mea (incuding drinks) provided by way of subsistence must not exceed 75 per person, excuding VAT and gratuities Payments may not be made to doctors or groups of doctors or to other prescribers, either directy or indirecty, for renta for rooms to be used for meetings When meetings are sponsored by pharmaceutica companies, that fact must be discosed in a of the papers reating to the meetings and in any pubished proceedings. The decaration of sponsorship must be sufficienty prominent to ensure that readers are aware of it at the outset Pharmaceutica companies must pubicy discose financia detais of sponsorship of UK heath professionas and other reevant decision makers in reation to attendance at meetings. Sponsorship in this context incudes registration fees and the costs of accommodation and trave, both inside and outside the UK. CODE OF PRACTICE 31

33 Cause 22 Suppementary Information Cause 22.1 Meetings and Hospitaity The provision of hospitaity is imited to refreshments/subsistence (meas and drinks), accommodation, genuine registration fees and the payment of reasonabe trave costs which a company may provide to sponsor a deegate to attend a meeting. The payment of trave expenses and the ike for persons accompanying the deegate is not permitted. Funding must not be offered or provided to compensate merey for the time spent by heath professionas in attending meetings. The payment of reasonabe honoraria and reimbursement of out of pocket expenses, incuding trave, for speakers, advisory board members and the providers of other professiona services, is permissibe. The arrangements for meetings must compy with Cause 22.1 with regard to hospitaity and venues. Companies shoud ony offer or provide economy air trave to deegates sponsored to attend meetings. Deegates may organise and pay at their own expense the genuine cost of an upgrade. For fights that are schedued to take onger than six hours companies may pay for an upgrade from economy to premium economy or simiar. Pharmaceutica companies may appropriatey hod or sponsor a wide range of meetings. These range from sma unchtime audio-visua presentations in a group practice, hospita meetings and meetings at postgraduate education centres, advisory board meetings, visits to research and manufacturing faciites, panning, training and investigator meetings for cinica trias and non-interventiona studies, aunch meetings for new products, management training courses, patient support group meetings and sateite symposia through to arge internationa meetings organised by independent bodies with sponsorship from pharmaceutica companies. With any meeting, certain basic principes appy: the meeting must have a cear educationa content the venue must be appropriate and conducive to the main purpose of the meeting; avish, extravagant or deuxe venues must not be used, companies must not sponsor or organise entertainment (such as sporting or eisure events) and companies shoud avoid using venues that are renowned for their entertainment faciities the subsistence associated with the meeting must be secondary to the nature of the meeting, must be appropriate and not out of proportion to the occasion any hospitaity provided must not extend to a spouse or other such person uness that person is a heath professiona or other reevant decision maker and quaifies as a proper deegate or participant at the meeting in their own right spouses and other accompanying persons, uness quaified as above, may not attend the actua meeting and may not receive any associated hospitaity at the company s expense; the entire costs which their presence invoves are the responsibiity of those they accompany. Administrative staff may be invited to meetings where appropriate. For exampe, receptionists might be invited to a meeting in a genera practice when the subject matter reated to practice administration. A usefu criterion in determining whether the arrangements for any meeting are acceptabe is to appy the question woud you and your company be wiing to have these arrangements generay known? The impression that is created by the arrangements for any meeting must aways be kept in mind. Meetings organised for groups of doctors, other heath professionas and/or for other reevant decsion makers etc. which are whoy or mainy of a socia or sporting nature are unacceptabe. Meetings organised by pharmaceutica companies which invove UK heath professionas at venues outside the UK are not necessariy unacceptabe. There have, however, to be vaid and cogent reasons for hoding meetings at such venues. These are that most of the invitees are from outside the UK and, given their countries of origin, it makes greater ogistica sense to hod the meeting outside the UK or, given the ocation of the reevant resource or expertise that is the object or subject matter of the meeting, it makes greater ogistica sense to hod the meeting outside the UK. As with meetings hed in the UK, in determining whether such a meeting is acceptabe or not, consideration must aso be given to the educationa programme, overa cost, faciities offered by the venue, nature of the audience, subsistence provided and the ike. As with any meeting it shoud be the programme that attracts deegates and not the associated hospitaity or venue. Promotiona materia which is dispayed or provided at internationa meetings hed outside the UK may, uness prohibited or otherwise reguated by oca aws and reguations, refer to medicines or their indications which are not registered in the country where the event takes pace, or which are registered under different conditions, so ong as any such materia is accompanied by a suitabe statement indicating countries where the product is registered and making cear that the product is not registered ocay. Any such promotiona materia which refers to the prescribing information authorized in a country or countries where the medicine is registered must be accompanied by an expanatory statement indicating that registration conditions differ internationay. The requirements reating to internationa meetings hed in the UK are set out in the suppementary information to Cause 3. The requirements of the Code do not appy to the provision of hospitaity other than to that referred to in Causes 22.1 and 27.2 and the suppementary information to Causes 23 and Cause 22.1 Meetings Organised by Affiiates Outside the UK Companies shoud remind their affiiates outside the UK that the ABPI Code of Practice must be compied with if UK heath professionas attend meetings which they organise regardess of whether such meetings occur in the UK or abroad. Cause 22.1 Certification of Meetings Pharmaceutica companies must ensure that a meetings which are panned are checked to see that they compy with the Code. Companies must have a written document that sets out their poicies on meetings and hospitaity and the associated aowabe expenditure. In addition, meetings which invove trave outside the UK must be formay certified as set out in Cause Cause 22.1 Heath Professionas Codes of Conduct The Genera Medica Counci is the reguatory body for doctors and is responsibe for giving guidance on standards of professiona conduct and on medica ethics. In its guidance, 32 CODE OF PRACTICE

34 the GMC advises that You must not aow any interests you may have to affect the way you prescribe for, treat, refer or commission services for patients and You must not ask for or accept from patients, coeagues or others any inducement, gift or hospitaity that may affect or be seen to affect the way you prescribe for, treat or refer patients or commission services for patients. You must not offer these inducements. The Genera Pharmaceutica Counci is the reguatory body for pharmacists and pharmacy technicians. The Counci s Standards of conduct, ethics and performance state Do not ask for or accept gifts, rewards or hospitaity that may affect, or be seen to affect, your professiona judgement. The Code of the Nursing & Midwifery Counci, Standards of conduct, performance and ethics for nurses and midwives, states You must not abuse your privieged position for your own ends and You must ensure that your professiona judgement is not infuenced by any commercia considerations. Cause 22.1 Continuing Professiona Deveopment (CPD) Meetings and Courses The provisions of this and a other reevant causes in the Code appy equay to meetings and courses organised or sponsored by pharmaceutica companies which are continuing professiona deveopment (CPD) approved. The fact that a meeting or course has CPD approva does not mean that the arrangements are automaticay acceptabe under the Code. The reevant provisions of the Code and, in particuar, those reating to hospitaity, must be observed. Cause 22.2 Maximum Cost of a Mea The maximum of 75 pus VAT and gratuities is appropriate ony in very exceptiona circumstances, such as a dinner at a residentia meeting for senior consutants or a dinner at a earned society conference with substantia educationa content. The cost of a mea (incuding drinks) shoud normay be we beow this figure. The requirements reating to hospitaity in Cause 22.1 and its suppementary information sti appy. The maximum of 75 pus VAT and gratuities (or oca equivaent) does not appy when a meeting is hed outside the UK in a european country where the nationa association is a member of EFPIA and thus covered by EFPIA Codes. In such circumstances the imits in the host country code woud appy. Information can be found at Cause 22.3 Payment of Room Renta This provision does not precude the payment of room renta to postgraduate medica centres and the ike. Payment of room renta to doctors or groups of doctors or to other prescribers is not permissibe even if such payment is made to equipment funds or patients comforts funds and the ike or to charities or companies. Cause 22.4 Sponsorship and Reports of Meetings Attention is drawn to Cause 9.10 which requires that a materia reating to medicines and their uses, whether promotiona or not, which is sponsored by a pharmaceutica company must ceary indicate that it has been sponsored by that company. It shoud be noted that where companies are invoved in the sponsorship and/or distribution of reports on meetings or symposia etc, these reports may constitute promotiona materia and thus be fuy subject to the requirements of the Code. Cause 22.5 Sponsorship of Attendance Discosure of this information must be carried out in accordance with Cause 24. Meetings at which attendance is sponsored by companies must aso compy with Cause The information required by Cause 22.5 must be pubicy discosed in respect of sponsorship for attendance at meetings hed in 2015 and each caendar year thereafter. The information which must be discosed comprises registration fees and the costs of accommodation and trave, both inside and outside the UK. The name of each recipient and the cost of the sponsorship of that recipient must be given. Where a transfer of vaue is made to a heath professiona indirecty via a heathcare organisation such a transfer shoud be discosed once ony, preferaby as being a transfer to the heath professiona. Discosure for Caendar Years 2013 and 2014 For discosures in reation to caendar years 2013 and 2014, the requirements and procedures in Cause 19.4 and its suppementary information in the Second 2012 Edition of the Code sti appy. Cause 23 The Use of Consutants 23.1 Heath professionas and other reevant decision makers may be used as consutants and advisors, whether in groups or individuay, for services such as speaking at and chairing meetings, invovement in medica/scientific studies, cinica trias or training services, participation at advisory board meetings, and participation in market research where such participation invoves remuneration and/or trave. The arrangements which cover these genuine consutancy or other services must, to the extent reevant to the particuar arrangement, fufi a the foowing criteria: a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services a egitimate need for the services must be ceary identified in advance of requesting the services and entering into arrangements with the prospective consutants the criteria for seecting consutants must be directy reated to the identified need and the persons responsibe for seecting the consutants must have the expertise necessary to evauate whether the particuar consutants meet those criteria CODE OF PRACTICE 33

35 the number of consutants retained must not be greater than the number reasonaby necessary to achieve the identified need the contracting company must maintain records concerning, and make appropriate use of, the services provided by consutants the hiring of the consutant to provide the reevant service must not be an inducement to prescribe, suppy, administer, recommend, buy or se any medicine the compensation for the services must be reasonabe and refect the fair market vaue of the services provided. In this regard, token consutancy arrangements must not be used to justify compensating heath professionas and other reevant decision makers in their written contracts or agreements with consutants, companies must incude provisions regarding the obigation of the consutant to decare that he/she is a consutant to the company whenever he/she writes or speaks in pubic about a matter that is the subject of the agreement or any other issue reating to that company. Simiary, companies that empoy, on a part-time basis, heath professionas that are sti practising their profession must ensure that such persons are obiged to decare their empoyment arrangement with the company whenever they write or speak in pubic about a matter that is the subject of the empoyment or any other issue reating to that company Pharmaceutica companies must pubicy discose detais of the fees paid to consutants in the UK, or to their empoyers on their behaf, for certain services rendered by them such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. It incudes payments to consutants in reation to research and deveopment work, incuding the conduct of cinica trias In addition to the information required to be made pubic by Cause 23.2, companies must pubicy discose detais of payments made to consutants in reation to market research (uness the company concerned is not aware of the identities of those participating in the market research) Fees, expenses and the ike due to consutants in reation to Causes 23.2 and 23.3 must be discosed whether paid directy to them or to their empoyers or to heathcare organisations or to companies or charities etc. Cause 23 Suppementary Information Cause 23 The Use of Consutants The term consutant in Cause 23 covers any heath professiona or other reevant decision maker consuted for the purposes described in Cause 23 regardess of their norma roes. Other reevant decsion makers covered by Cause 23 are those who coud infuence in any way the prescription, suppy, administration, recommendation, purchase or sae of any medicine. Cause 23 Patient Organisations The provision of services to pharmaceutica companies by patient organisations is covered by Cause Cause 23.1 The Use of Consutants The requirement that contracts or agreements with consutants must incude provisions regarding their obigation to decare the arrangement whenever they write or speak in pubic appies to contracts entered into or renewed on or after 1 May Companies are encouraged to renegotiate existing contracts to incude such provisions at their eariest convenience. Limited market research, such as one-off teephone interviews or mai/emai/internet questionnaires was excuded from the scope of Cause 20.1 of the 2012 Code, provided that the consutant was not consuted in a recurring manner (either with respect to the frequency of the cas generay or of cas reating to the same research) and that the remuneration was minima. Foowing impementation of Cause 20.3 of the 2012 Code, payments made in reation to this imited market research must be made pubicy avaiabe in accordance with that cause. If heath professionas or other reevant decsion makers attend events in a consutant or advisory capacity the reevant provisions of Cause 22 appy. Cause 23.2 Discosure The information required by Cause 23.2 must be pubicy discosed in respect of the caendar year 2015 and each caendar year thereafter. Discosure must be carried out in accordance with Cause 24. The information which must be discosed is the tota amount paid in a caendar year to each consutant who has provided services. Companies may, of course, give greater detai, for exampe by giving separate figures for different categories of service. Fees and agreed expenses shoud be discosed separatey. The names of the consutants must be discosed except in reation to payments in reation to research and deveopment work, incuding cinica trias, as defined beow, where discosure shoud be on an aggregate basis. Cause 23.2 Research and Deveopment Transfers of Vaue For the purpose of discosure research and deveopment transfers of vaue are transfers of vaue to heath professionas or heathcare organisations reated to the panning or conduct of: non-cinica studies (as defined in the OECD Principes of Good Laboratory Practice) cinica trias (as defined in Directive 2001/20/EC) non-interventiona studies that are prospective in nature and invove the coection of data from, or on behaf of, individua or groups of heath professionas specificay for the study. Costs that are subsidiary to these activities can be incuded in the aggregate amount. Cause 23.3 Discosure Cause 23.3 reates ony to market research using consutants where the pharmaceutica company knows the identity of the 34 CODE OF PRACTICE

36 consutants. This is because the focus of the requirements concerning transparency is on areas where there are direct reationships between the parties and that is not so where the company does not know the identity of the participants. Cause 24 Transfers of Vaue to Heath Professionas and Heathcare Organisations 24.1 Companies must document and pubicy discose certain transfers of vaue made directy or indirecty to heath professionas and heathcare organisations ocated in Europe The transfers of vaue covered by Cause 24.1 are: joint working in accordance with Cause 20 donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Causes 19.1 and 19.2 contracts between companies and institutions, organisations and associations in accordance with Cause 21 sponsorship of attendance by heath professionas and other reevant decision makers at meetings in accordance with Cause 22.5 fees and expenses paid to heath professionas and other reevant decision makers, or to their empoyers on their behaf, in accordance with Causes 23.2, 23.3 and 23.4 contributions towards the costs of meetings paid to heathcare organisations or to third parties managing events on their behaf, which may incude sponsorship of heath professionas by way of registration fees and accommodation and trave Cause 24.1 does not appy to transfers of vaue to patient organisations. These transfers of vaue are covered by Causes 27.7 and Discosures must be made annuay in respect of each caendar year. Discosure must be in the first six months after the end of the caendar year in which the transfers of vaue were made. Discosure for Caendar Years 2013 and 2014 For discosures in reation to the caendar years 2013 and 2014, the requirements and procedures in Causes 20.2 and 20.3 and their suppementary information in the Second 2012 Edition of the Code sti appy The information discosed must remain in the pubic domain for at east three years from the time of discosure Companies must document a discosures and retain the records for at east five years after the end of the caendar year to which they reate Different categories of transfers of vaue to individua heath professionas can be aggregated on a category by category basis, provided that itemised discosure woud be made avaiabe upon request to the reevant recipient or the reevant authorities. Payments to heathcare organisations are required to be discosed on a per activity basis Where a transfer of vaue is made to a heath professiona indirecty via a heathcare organisation such a transfer shoud be discosed once ony, preferaby as being a transfer to the heath professiona Where recipients of transfers of vaue cannot be identified for ega reasons, the amount attributabe to such transfers must be discosed on an aggregate basis. The number of recipients invoved must be stated together with the percentage of a recipients that they represent and the aggregate amount attributabe to transfers of vaue to such recipients Each company providing transfers of vaue must pubish a note summarising the methodoogies used by it in preparing the discosures and identifying each category of transfer of vaue. The note, incuding a genera summary and/or country specific considerations, must describe the recognition methodoogies appied and shoud incude the treatment of muti-year contracts, VAT and other tax aspects, currency aspects and other issues reating to the timing and amount of transfers of vaue for the purposes of this Code. Cause 24 Suppementary Information Cause 24.1 Transfers of Vaue The term transfer of vaue is defined in Cause The term Europe comprises those countries that are within the EU and other countries with a trade association that is a member of EFPIA. The term heath professiona in reation to discosure of transfers of vaue aso incudes any empoyee of a pharmaceutica company whose primary occupation is that of a practising heath professiona as defined in Cause 1.4. Discosure is required even if the payments etc are made by overseas affiiates, head offices in the UK or overseas and UK based offices. Cause 24.1 Consent to Discosure Companies are encouraged to incude in a contract invoving a transfer of vaue provisions regarding the consent of the recipient to its discosure. In addition, companies are encouraged to renegotiate existing contracts at their eariest convenience to incude such consent to discosure. Companies must ensure that they have appropriate arrangements in pace to awfuy discose information about transfers of vaue. CODE OF PRACTICE 35

37 Cause 24.1 Mode of Discosure There wi be a centra patform for discosure in the UK which companies must use. The tempate to be used is avaiabe from the Authority s website Cause 24.1 Date of Impementation The information required by Cause 24.1 must be discosed in respect of transfers of vaue made in 2015 and each caendar year thereafter. The discosure of information about certain transfers of vaue was a requirement of the Second 2012 Edition of the Code and its immediate predecessors. The provisions in the Second 2012 Edition of the Code (Causes 18.6, 19.4, 20.2 and 20.3) continue to appy in reation to transfers of vaue made in caendar years prior to Cause 24.2 Further Information The causes of the Code noted in Cause 24.2 shoud be consuted for further information about the requirements. In addition, the requirements of Causes 22.1 and 22.5 shoud be borne in mind in reation to sponsorship of meetings. Cause 25 Scientific Services 25.1 Companies must have a scientific service to compie and coate a information, whether received from medica representatives or from any other source, about the medicines which they market Companies must aso have a scientific service to dea with the approva and supervision of non- interventiona studies. This scientific service must incude a registered medica practitioner or a pharmacist registered in the UK, who wi be responsibe for the oversight of noninterventiona studies (incuding the review of any responsibiities reating to such studies, particuary those Cause 26 Reations with the Pubic and the Media 26.1 Prescription ony medicines must not be advertised to the pubic. This prohibition does not appy to vaccination campaigns carried out by companies and approved by the heath ministers Information about prescription ony medicines which is made avaiabe to the pubic either directy or indirecty must be factua and presented in a baanced way. It must not raise unfounded hopes of successfu treatment or be miseading with respect to the safety of the product. Statements must not be made for the purpose of encouraging members of the pubic to ask their heath professiona to prescribe a specific prescription ony medicine Any materia which reates to a medicine and which is intended for patients taking that medicine must incude the statement beow or a simiar one: Reporting of side effects If you get any side effects, tak to your doctor, pharmacist or nurse. This incudes any possibe side effects not isted in the package eafet. You can aso given to medica representatives). That person must state in writing that he or she has examined the protoco reating to the non- interventiona study and that in his or her beief it is in accordance with the requirements of the Code. Cause 25 Suppementary Information Causes 25.1 and 25.2 Scientific Services Companies are free to decide whether there is one scientific service in charge of both responsibiities or separate services with ceary deineated duties. Cause 14 does not appy to the examination of noninterventiona studies. report side effects directy via the Yeow Card Scheme at By reporting side effects you can hep provide more information on the safety of this medicine. When the materia reates to a medicine which is subject to additiona monitoring an inverted back equiatera triange must be incuded on it together with the statement beow or a simiar one: This medicine is subject to additiona monitoring. This wi aow quick identification of new safety information. You can hep by reporting any side effects you may get. See for how to report side effects Requests from individua members of the pubic for advice on persona medica matters must be refused and the enquirer recommended to consut his or her own doctor or other prescriber or other heath professiona The introduction of a new medicine must not be made known to the pubic unti reasonabe steps have been taken to inform the medica and pharmaceutica professions of its avaiabiity Companies are responsibe for information about their products which is issued by their pubic reations agencies. 36 CODE OF PRACTICE

38 Cause 26 Suppementary Information Cause 26.1 Advertising of Medicines to the Pubic The advertising of prescription ony medicines to the pubic is aso prohibited by the reevant reguations reating to advertising. The promotion of medicines to the pubic for sef medication purposes is covered by the Consumer Code of the Proprietary Association of Great Britain (PAGB). Cause 26.2 Information to the Pubic This cause aows for the provision of non-promotiona information about prescription ony medicines to the pubic either in response to a direct enquiry from an individua, incuding enquiries from journaists, or by dissemination of such information via press conferences, press announcements, teevision and radio reports, pubic reations activities and the ike. It aso incudes information provided by means of posters distributed for dispay in surgery waiting rooms etc and reference information made avaiabe by companies on their websites or otherwise as a resource for members of the pubic. Any information so provided must observe the principes set out in this cause; that is, it shoud be factua, baanced and must not be made for the purpose of encouraging members of the pubic to ask their doctors or other prescribers to prescribe a specific prescription ony medicine. It must not constitute the advertising of prescription ony medicines to the pubic prohibited under Cause The provisions of Cause 26.4 must be observed if an enquiry is from an individua member of the pubic. Information to the pubic fas into one of three categories depending on its purpose, how it is suppied and how the pubic is made aware of the information. Companies shoud take particuar care if they use socia media. Proactive information is suppied to the pubic without a direct request. This incudes bookets on diseases and/or medicines suppied directy or via a heath professiona, press reeases, briefings, conferences, maiings to patient organisations and disease awareness advertising. Reference information is intended to provide a comprehensive up-to-date resource that companies shoud make avaiabe on their websites or by way of a ink from their website or by some other means. The primary purpose of reference information is to be a ibrary resource for members of the pubic giving information reating to prescription ony medicines which have marketing authorizations. Pharmaceutica companies are not obiged to provide reference information but it is considered good practice to provide as a minimum the reguatory information comprising the summary of product characteristics (SPC), the package eafet (PIL) and the pubic assessment report (PAR) (UK or European) where such a document exists. Reference information may aso incude the registration studies used for marketing authorization appications and variations and any other studies pubished or not incuding those referred to in the SPC, PIL, EPAR or UKPAR or avaiabe on cinica tria databases. Reference information may aso incude materia suppied for heath technoogy assessments to bodies such as the Nationa Institute for Heath and Care Exceence (NICE), the A Waes Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC). Reference information may aso incude medicine guides where avaiabe, studies (pubished or not), information about diseases and information about specific medicines etc. Where companies decide to make reference information avaiabe this must represent fairy the current body of evidence reating to a medicine and its benefit/risk profie. Reactive information is suppied to the pubic in response to a direct request and must be imited to that information necessary to respond to the request. It is good practice to incude the summary of product characteristics with a press reease or press pack reating to a medicine. Companies shoud aso consider incuding references to other credibe sources of information about a condition or a medicine. Particuar care must be taken in responding to approaches from the media to ensure that the provisions of this cause are uphed. In the event of a compaint which reates to the provisions of this cause, companies wi be asked to provide copies of any information suppied, incuding copies of any reevant press reeases and the ike. This information wi be assessed to determine whether it fufis the requirements of this cause. Pubic assessment reports (European or UK), summaries of product characteristics and package eafets may be provided to members of the pubic on request. Companies may provide members of the heath professions with materia concerning a medicine with a view to its provision to patients to whom the medicine has aready been prescribed. Such materia must be factua and non-promotiona and ceary state the intended audience. A company may conduct a disease awareness or pubic heath campaign provided that the purpose is to encourage members of the pubic to seek treatment for their symptoms whie in no way promoting the use of a specific medicine. The use of brand or non-proprietary names and/or restricting the range of treatments described in the campaign might be ikey to ead to the use of a specific medicine. Particuar care must be taken where the company s product, even though not named, is the ony medicine reevant to the disease or symptoms in question. Attention is drawn to the Disease Awareness Campaigns Guideines produced by the Medicines and Heathcare Products Reguatory Agency. The requirements of Cause 7 reating to information (Causes 7.2, 7.4, 7.5, 7.8, 7.9, 7.10 and 7.11) aso appy to information to the pubic. Meetings organised for or attended by members of the pubic, journaists and patient organisations must compy with Cause 22. Items for patients or for use by patients are covered in Cause and its suppementary information. Cause 26.2 Financia Information Information made avaiabe in order to inform sharehoders, the Stock Exchange and the ike by way of annua reports and announcements etc may reate to both existing medicines and those not yet marketed. Such information must be factua and presented in a baanced way. Business press reeases shoud identify the business importance of the information. Cause 26.2 Information to Current or Prospective Empoyees Information about pharmaceutica companies provided to current or prospective empoyees may reate to both existing medicines and those not yet marketed. Such information must be factua and presented in a baanced way. CODE OF PRACTICE 37

39 Cause 26.2 Approva of Information Information on medicines made avaiabe under this cause other than responses from medica information departments or simiar to unsoicited enquiries from the pubic must be certified in advance as required by Cause Cause 26.2 Heath Technoogy Assessments Companies may suppy information to reevant patient organisations, the pubic or patients in reation to forthcoming heath technoogy assessments by pubic nationa organisations such as NICE, AWMSG or SMC, provided the information is accurate, not miseading, not promotiona in nature and otherwise compies with Cause Cause 26.3 Obigatory Wording The obigatory wording required corresponds to that required for package eafets by the European Quaity Review of Documents Group which updated the requirements in The Human Medicines Reguations If the suggested wording is not used the same meaning must be conveyed. In the event that the website address given in Cause 26.3 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 26.3 Back Triange Symbo Detais of the back triange symbo can be found in the suppementary information to Cause Cause 26.4 Requests for Information or Advice on Persona Medica Matters This cause prohibits the provision of advice on persona medica matters to individua members of the pubic requesting it. The intention behind this prohibition is to ensure that companies do not intervene in the patient/doctor or patient/prescriber reationship by offering advice or information which propery shoud be in the domain of the doctor or other prescriber. Pharmaceutica companies can provide information appropriate to support the use of medicines and enhance patient wefare. Emergency advice, for exampe action needed in the event of an overdose, can be provided. Other information may aso be given, incuding information on medicines prescribed for the enquirer, provided that it compies with the requirements of Causes 26.1 and 26.2 and does not impinge on the principe behind this cause. For exampe, answering requests from members of the pubic as to whether a particuar medicine contains sucrose or some other inactive ingredient, or whether there woud be probems associated with drinking acoho whist taking the medicine or whether the medicine shoud be taken before or after a mea, is acceptabe. Particuar care needs to be taken with regard to enquiries reating to adverse reactions, the indications for a medicine and suchike. A requests from members of the pubic must be handed with great care and a company shoud refer the enquirer to other sources where appropriate. These might incude heath professionas, NHS Choices, NHS 111, their equivanents in the devoved nations and patient organisations, etc. A request from a patient for information may in some instances best be handed by passing the information to the patient s doctor or other prescriber for discussion with them rather than providing the information direct to the patient concerned. This shoud not be done without the patient s consent. Cause 27 Reationships with Patient Organisations 27.1 Pharmaceutica companies can interact with patient organisations or any user organisation such as disabiity organisations, carer or reative organisations and consumer organisations to support their work, incuding assistance in the provision of appropriate information to the pubic, patients and carers. Companies must respect the independence of patient organisations When working with patient organisations, companies must ensure that the invovement of the company is made cear and that a of the arrangements compy with the Code. This incudes the need to decare sponsorship (Cause 27.9) and the prohibition on advertising prescription ony medicines to the pubic (Cause 26.1). The requirements of Cause 22, which covers meetings for heath professionas and other reevant decision makers, aso appy to pharmaceutica companies supporting patient organisation meetings Companies working with patient organisations must have in pace a written agreement setting out exacty what has been agreed, incuding funding, in reation to every significant activity or ongoing reationship No company may require that it be the soe funder of a patient organisation or any of its programmes A company must not make pubic use of a patient organisation s ogo or proprietary materia without the organisation s written agreement. In seeking such permission, the specific purpose and the way in which the ogo or materia wi be used must be ceary stated A company must not seek to infuence the text of patient organisation materia in a manner favourabe to its own commercia interests. This does not precude a company from correcting factua inaccuracies Each company must make pubicy avaiabe, at a nationa or European eve, a ist of patient organisations to which it provides financia support and/or significant indirect/non-financia support, which must incude a description of the nature of the support that is sufficienty compete to enabe the average reader to form an understanding of the significance of the support. The ist of organisations being given support must be updated at east once a year. The pubished information must incude the monetary vaue of financia support and of invoiced costs. For significant non-financia support that cannot be assigned a meaningfu monetary vaue, the pubished information must describe ceary the non-monetary vaue that the organisation receives. 38 CODE OF PRACTICE

40 27.8 Contracts between companies and patient organisations under which they provide any type of services to companies are ony aowed if such services are provided for the purpose of supporting heathcare or research. Patient organisations may be engaged as experts and advisors for services such as participation at advisory board meetings and speaker services. The arrangements that cover consutancy or other services must, to the extent reevant to the particuar arrangement, fufi a the foowing criteria: a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services a egitimate need for the services must be ceary identified and documented in advance of requesting the services and entering into the arrangements the criteria for seecting services must be directy reated to the identified need and the persons responsibe for seecting the service must have the expertise necessary to evauate whether the particuar experts and advisors meet those criteria the extent of the service must not be greater than is reasonaby necessary to achieve the identified need the contracting company must maintain records concerning, and make appropriate use of, the services the engaging of patient organisations must not be an inducement to recommend a particuar medicine the compensation for the services must be reasonabe and not exceed the fair market vaue of the services provided. In this regard, token consutancy arrangements must not be used to justify compensating patient organisations in their written contracts with patient organisations, companies are strongy encouraged to incude provisions regarding an obigation of the patient organisation to decare that they have provided paid services to the company whenever those concerned write or speak in pubic about a matter that is the subject of the agreement or any other issue reating to that company each company must make pubicy avaiabe, at a nationa or European eve, a ist of patient organisations that it has engaged to provide significant contracted services, which must incude a description of the nature of the services provided that is sufficienty compete to enabe the average reader to form an understanding of the arrangement without the necessity to divuge confidentia information. Companies must aso make pubicy avaiabe the tota amount paid per patient organisation over the reporting period. The ist of organisations engaged must be updated at east once a year Companies must ensure that their sponsorship is aways ceary acknowedged from the outset. The wording of the decaration of sponsorship must accuratey refect the nature of the company s invovement. Cause 27 Suppementary Information Cause 27.1 Other Codes and Guideines There are other codes and guideines which cover patient groups, incuding Charity Commission requirements. Cause 27.2 Purpose of Materias and Activities Companies shoud take into account the purpose of materias and/or activities. The purpose of information suppied to a patient organisation must be made cear. For exampe, there is a difference between providing information to be suppied to the members of a patient organisation and providing background information to enabe a patient organisation to respond to a heath technoogy assessment or simiar. Cause 27.2 Hospitaity for Carers Athough the requirements in Cause 22 reating to the provision of hospitaity at meetings appy where pharmaceutica companies support patient organisation meetings and their representatives, in exceptiona circumstances, in the case of cear heath needs such as disabiity, companies can pay for subsistence, accommodation, genuine registration fees and reasonabe trave costs for an accompanying carer. Cause 27.3 Written Agreements The written agreement must incude: the name of the activity the names of the organisations invoved (pharmaceutica company, patient organisations and any third parties which wi be brought in to hep) the type of activity (eg unrestricted grant, specific meeting or pubication etc) the objectives the respective roes of the company and the patient organisation the time-frame the amount of funding a description of significant indirect/non-financia support (eg the donation of pubic reations agency time or free training courses) a statement that a parties are fuy aware that sponsorship must be ceary acknowedged and apparent from the start the code or codes of practice which wi appy the signatories to the agreement the date of the agreement. Attention is drawn to the certification requirements as set out in Cause Cause 27.5 Use of Patient Organisation Logos or Materia Even with the organisation s permission the use of its ogo or materia must not be such as to otherwise breach the Code. CODE OF PRACTICE 39

41 Cause 27.7 Further Information An indication of the patient organisation s tota income and/or the company s support as a percentage of the patient organisation s tota income may be given. Neither is obigatory. Companies are encouraged to be prepared to make avaiabe upto-date information about such activities at any time in response to enquiries. Causes 27.7 and 27.8 Transfers of Vaue to Patient Organisations Transfers of vaue to patient organisations made in accordance with Causes 27.7 and 27.8 are not subject to the requirements reating to transfers of vaue set out in Cause 24. Cause 24.3 excudes them from its scope. Cause 28 The Internet 28.1 Promotiona materia about prescription ony medicines directed to a UK audience which is provided on the Internet must compy with a reevant requirements of the Code Information or promotiona materia about medicines covered by Cause 28.1 which is paced on the Internet outside the UK wi be regarded as coming within the scope of the Code if it was paced there by a UK company or an affiiate of a UK company or at the instigation or with the authority of such a company and it makes specific reference to the avaiabiity or use of the medicine in the UK Information about medicines covered by Causes 28.1 and 28.2 which is provided on the Internet and which is intended for members of the pubic must compy with Cause A medicine covered by Cause 28.1 may be advertised in a reevant independenty produced eectronic journa intended for heath professionas or other reevant decision makers which can be accessed by members of the pubic Pubic assessment reports (European or UK), summaries of product characteristics, package eafets and reference materia for prescription ony medicines may be incuded on the Internet and be accessibe by members of the pubic provided that they are not presented in such a way as to be promotiona in nature It shoud be made cear when a user is eaving any of the company s sites, or sites sponsored by the company, or is being directed to a site which is not that of the company. Cause 28 Suppementary Information Cause 28.1 Access Uness access to promotiona materia about prescription ony medicines is imited to heath professionas and other reevant decsion makers, a pharmaceutica company website or a company sponsored website must provide information for the pubic as we as promotion to heath professionas with the sections for each target audience ceary separated and the intended audience identified. This is to avoid the pubic needing to access materia for heath professionas uness they choose to. The MHRA Bue Guide states that the pubic shoud not be encouraged to access materia which is not intended for them. Cause 28.4 Advertisements in Eectronic Journas It shoud be noted that the MHRA Bue Guide states that each page of an advertisement for a prescription ony medicine shoud be ceary abeed as intended for heath professionas. Cause 28.5 MHRA Guidance The MHRA Bue Guide states that the pubic shoud not need to access non-uk websites or non-uk parts of websites to obtain basic information about a company s products, such as package eafets, summaries of product characteristics, pubic assessment reports and other non-promotiona materia. It is good practice for each page of a company website to incude a statement identifying the intended audience. Cause 28.5 Information on Cinica Trias Information on cinica trias as agreed in the current Joint Position on the Discosure of Cinica Tria Information via Cinica Tria Registries and Databases and the current Joint Position on the Pubication of Cinica Tria Resuts in the Scientific Literature may be avaiabe at a UK or a non UK website. Attention is drawn to Cause 13.1 and its suppementary information. Cause 28.6 Sites Linked via Company Sites Sites inked via company sites are not necessariy covered by the Code. Cause 29 Compiance with Undertakings When an undertaking has been given in reation to a ruing under the Code, the company concerned must ensure that it compies with that undertaking. 40 CODE OF PRACTICE

42 PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY Constitution and Procedure Introduction 42 Page Structure and Responsibiities 1 Prescription Medicines Code of Practice Authority 42 2 Code of Practice Pane Constitution and Procedure 42 3 Code of Practice Appea Board Constitution 44 4 Code of Practice Appea Board Procedure 44 Compaints Procedure 5 Action on Compaints 45 6 Compaints Arising from Media Criticism 46 7 Code of Practice Pane Ruings 47 8 Code of Practice Pane Reports to the Code of Practice Appea Board 48 9 Action on Compaints about Safety from the Medicines and Heathcare Products Reguatory Agency Code of Practice Appea Board Ruings Reports to the Code of Practice Appea Board Code of Practice Appea Board Reports to the ABPI Board of Management Case Reports 50 Genera Provisions 14 Time Periods for Responding to Matters under the Code Withdrawa of Compaints and Notices of Appea Code of Practice Levy and Charges Scrutiny Provision of Advice and Assistance with Conciiation Amendments to the Code of Practice and Constitution and Procedure Annua Report 52 CODE OF PRACTICE 41

43 PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY CONSTITUTION AND PROCEDURE Operative on 1 January INTRODUCTION The Code of Practice for the Pharmaceutica Industry is administered by the Prescription Medicines Code of Practice Authority. The Authority is responsibe for the provision of advice, guidance and training on the Code as we as for the compaints procedure. It is aso responsibe for arranging for conciiation between companies when requested to do so and for arranging for the scrutiny of advertising and meetings on a reguar basis. The Authority is not an investigatory body as such. It asks the respondent company for a compete response and may ask the parties to a case for further information in order to carify the issues. It is essentiay an adversaria process in which the evidence to be taken into account comes from the compainant and the respondent company, though the Authority can seek evidence from third parties where necessary. A compainant has the burden of proving their compaint on the baance of probabiities. The system is designed so that both parties can participate fuy in the process. Athough anonymous compaints are accepted, it is preferabe if compainants from outside the industry provide a name, contact detais and reevant information about their interests in the matter of compaint. The names of individuas compaining from outside the pharmaceutica industry are kept confidentia. In exceptiona cases it may be necessary for a company to know the identity of the compainant so that the matter can be propery investigated. Even in these instances, the name of the compainant is ony discosed with the compainant s permission. A compaints are judged on the evidence provided by the parties. The weight to be attached to any evidence may be adversey affected if the source is anonymous and thus in some instances it wi not be possibe for such a compaint to proceed. 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 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 [email protected]. STRUCTURE AND RESPONSIBILITIES 1 Prescription Medicines Code of Practice Authority 1.1 The Prescription Medicines Code of Practice Authority (the Authority ) is responsibe for the administration of the Code of Practice for the Pharmaceutica Industry (the Code ) incuding the provision of advice, guidance and training on the Code. It is aso responsibe for arranging for conciiation between companies when requested to do so and for arranging for the scrutiny of advertising and meetings on a reguar basis. 1.2 The Authority aso administers the compaints procedure by which compaints made under the Code are considered by the Code of Practice Pane (the Pane ) and, where required, by the Code of Practice Appea Board (the Appea Board ). 1.3 The Authority is appointed by and reports to the Board of Management of the Association of the British Pharmaceutica Industry (ABPI) (the ABPI Board ) and consists of the Director, Deputy Director, Secretary and Deputy Secretary. Notwithstanding the above, the Director reports to the Appea Board for guidance on the interpretation of the Code and the operation of the compaints procedure and to the President of the ABPI for administrative purposes. In the absence of the Director, the Deputy Director is authorized to act on his behaf. In the absence of the Director and Deputy Director, the Secretary is authorized to act on the Director s behaf. 1.4 To faciitate the compaints procedure by ensuring that the requisite information is avaiabe, the Director may request copies of any reevant materia from a pharmaceutica company, incuding copies of the certificates authorizing any such materia and copies of reevant briefing materia for representatives. 1.5 The Director may consut the Appea Board upon any matter concerning the Code or its administration. 2 Code of Practice Pane Constitution and Procedure 2.1 The Pane consists of the members of the Authority and meets as business requires to consider compaints made under the Code. The member of the Authority who acted as case preparation manager for a particuar case must not participate when the Pane considers it or be present when it does so. The parties have no right to appear or be represented before the Pane. 2.2 Two members of the Authority form a quorum for a meeting of the Pane. Decisions are made by majority voting. The Director or, in his absence, the Deputy Director or, in his absence, the Secretary, acts as Chairman of the Pane and has both an origina and a casting vote. 42 CODE OF PRACTICE

44 COMPLAINT TO PRESCRIPTION MEDICINES CODE OF PRACTICE AUTHORITY CODE OF PRACTICE PANEL CAN REPORT COMPANIES TO APPEAL BOARD COMPLAINANT ADVISED OF RULING RESPONDENT ADVISED OF RULING ACCEPTED APPEALED APPEALED ACCEPTED CODE OF PRACTICE APPEAL BOARD CAN REPORT COMPANIES TO ABPI BOARD ABPI BOARD OF MANAGEMENT CODE OF PRACTICE 43

45 Ruings are made on the basis that a compainant has the burden of proving their compaint on the baance of probabiities. 2.3 The Director may obtain expert assistance in any fied. Expert advisers who are consuted may be invited to attend a meeting of the Pane but have no voting rights. 3 Code of Practice Appea Board Constitution 3.1 Vacancies for independent members of the Appea Board, incuding the Chairman, are advertised in appropriate journas and/or the nationa press. The Appea Board and its Chairman are appointed by the ABPI Board. The appointment of independent members to the Appea Board, incuding the Chairman, is made foowing consutation with the Medicines and Heathcare Products Reguatory Agency. 3.2 The Appea Board comprises: an independent, egay quaified Chairman three independent registered medica practitioners appointed foowing consutation with the British Medica Association, one with recent experience as a genera practitioner and one with recent experience as a hospita consutant treating patients one independent registered pharmacist appointed foowing consutation with the Roya Pharmaceutica Society. one independent registered nurse prescriber appointed foowing consutation with the Roya Coege of Nursing one independent member representative of the interests of patients one member from an independent body invoved in providing information on medicines one independent ay member four registered medica practitioners who are medica directors or senior executives of pharmaceutica companies four directors or senior executives of pharmaceutica companies. One of the members from pharmaceutica companies may be retired, provided that the initia appointment is made within one year of the date of retirement. 3.3 The Chairman of the Appea Board is appointed for a term of five years which may be renewed. Members of the Appea Board are each appointed for a term of three years. Members may be reappointed but may serve for no more than two consecutive terms. In exceptiona circumstances the Chairman may nominate a member who has served two terms for reappointment for a third term. A member of the Appea Board who has served two or, foowing the Chairman s nomination, three consecutive terms of service is eigibe for reappointment after a minimum interva of one year. A member of the Appea Board appointed prior to 1 January 2006 is eigibe to serve for two or, foowing the Chairman s nomination, three further consecutive terms foowing competion of their current term and is eigibe for reappointment after a minimum interva of one year. 3.4 The Director is responsibe for providing appropriate administrative support to the Appea Board incuding the provision of case papers. The Director, Deputy Director, Secretary and Deputy Secretary of the Authority may be present as observers at a meeting of the Appea Board during the consideration of an appea or a report under Paragraph 11 beow ony at the invitation of the Chairman and with the agreement of the party or parties invoved in the appea or report in question. 4 Code of Practice Appea Board Procedure 4.1 The Appea Board meets as business requires to consider appeas under the Code and any other matter which reates to the Code. The Appea Board receives reports on a compaints which have been submitted under the Code and detais of the action taken on them. 4.2 The Chairman and seven members of the Appea Board constitute a quorum. Four of those present, in addition to the Chairman, must be independent members, at east one of whom must be a registered medica practitioner, and there must aso be present three members from pharmaceutica companies, at east one of whom must be a registered medica practitioner. For the consideration of any particuar case, or a report under Paragraph 11 beow, independent members, incuding the Chairman, must be in a majority. In the event that a quorum cannot be attained for the consideration of a case because of the number of members barred under Paragraph 4.4 beow, or for any other reason, the Chairman may co-opt appropriate persons who are former members of the Appea Board, or who are on a ist of persons approved for co-option to the Appea Board, so as to enabe a quorum to be achieved. The ist of persons approved for co-option is drawn up foowing procedures simiar to those for appointing members of the Appea Board. No one may be co-opted in reation to any case in which he has acted as a referee in accordance with Paragraphs 5.1, 5.2, 5.3, 7.2, 7.4, 7.5 and 7.6 beow. 4.3 Decisions are made by majority voting. The Chairman has both an origina and a casting vote. Ruings are made on the basis that a compainant has the burden of proving their compaint on the baance of probabiities. 44 CODE OF PRACTICE

46 4.4 If a member of the Appea Board is concerned in a case either as compainant or respondent, that member does not receive copies of the papers circuated in connection with the case and is required to withdraw from the Appea Board during its consideration. The compainant and the respondent are advised in advance of the membership of the Appea Board, incuding potentia co-optees, and asked if they have any objections to particuar members and the grounds for such objections. Any member in respect of whom there are vaid objections must withdraw from the Appea Board during consideration of the case. The Chairman determines whether objections are vaid. Members of the Appea Board must decare any other interest in a case prior to its consideration. Having consuted the representatives of the parties (if present), the Chairman determines whether it is appropriate for a particuar member to remain for the consideration of the case. 4.5 The Chairman may obtain expert assistance in any fied. Expert advisers may be invited to attend a meeting of the Appea Board but have no voting rights. 4.6 When an appea is considered by the Appea Board, both the compainant and the respondent company are entited to appear or be represented. The first presentation in reation to a ruing which is appeaed is made by the appeant. A company may not be represented before the Appea Board by a representative who is aso a member of the Appea Board except with the consent of the Chairman. Such consent may be given ony if the member of the Appea Board can satisfy the Chairman that no other person within his company can propery represent it in the case in question. 4.7 Where an appea is brought which is concerned with an issue of fact between a compainant and the company concerned which cannot be propery resoved without the ora evidence of the persons directy invoved, the Chairman may invite such persons to attend and give evidence. COMPLAINTS PROCEDURE 5 Action on Compaints 5.1 When the Director receives information from which it appears that a company (being either a member of the ABPI or a company which, athough not a member, has agreed to compy with the Code and accept the jurisdiction of the Authority) may have contravened the Code, the Director must assign a member of the Authority (who may be the Director) to be the case preparation manager to process the matter and, if appropriate, prepare case papers for the Pane. The case preparation manager must not divuge to other members of the Authority detais of matters being processed unti the forma case papers are provided to the Pane for consideration as provided for in Paragraph 5.5 beow. The Director is responsibe for ensuring that the preparation of a case and the adjudication of it are carried out by different members of the Authority and must take steps to make certain that this separation is maintained in the event of absences of those invoved. The Director may deegate to a case preparation manager one or more of his responsibiities under this Constitution and Procedure when he considers it appropriate and necessary to do so. The case preparation manager: determines whether a case shoud go before the Pane may invite evidence from third parties when considered to be appropriate even though the primary responsibiity for the provision of evidence ies with the parties to a case may deay processing a compaint if the facts are essentiay simiar to those before an externa forum, such as an empoyment tribuna; this does not appy to matters before the Medicines and Heathcare Products Reguatory Agency may amagamate a compaint with an ongoing compaint or compaints where two or more compaints are based on essentiay the same evidence. When a compaint is deayed or amagamated, as above, the compainant may appea against the deay or amagamation to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. 5.2 The managing director or chief executive or equivaent of the company concerned is requested to provide a compete response to the matters of compaint. To assist companies in ensuring that a compete response is submitted the case preparation manager may suggest reevant supporting materia to be suppied. It is nonetheess the responsibiity of the respondent to ensure that a fu response is submitted. If the compainant is not a pharmaceutica company the case preparation manager may suggest the causes of the Code to be addressed. CODE OF PRACTICE 45

47 If a compaint is received about a company other than one of those referred to in Paragraph 5.1 above, it is invited by the case preparation manager to agree to compy with the Code and accept the jurisdiction of the Authority (uness it has previousy decined to do so). In the absence of such agreement, the compaint is not proceeded with and the compainant is advised to refer the matter to the Medicines and Heathcare Products Reguatory Agency. Uness the information is discosed in the compaint, a compainant other than a pharmaceutica company is asked whether or not they have any commercia, financia or other interest in the matter of compaint or in the company concerned, such as whether the compainant is an empoyee or exempoyee, or in a competitor. Such interests wi be discosed to the respondent company and wi normay be incuded in the case report. If a compaint concerns a matter cosey simiar to one which has been the subject of a previous adjudication, it may be aowed to proceed at the discretion of the Director if new evidence is adduced by the compainant or if the passage of time or a change in circumstances raises doubts as to whether the same decision woud be made in respect of the current compaint. The Director shoud normay aow a compaint to proceed if it covers matters simiar to those in a decision of the Pane where no breach of the Code was rued and which was not the subject of appea to the Appea Board. If a compainant does not accept a decision of the Director that a compaint shoud not be proceeded with because a simiar compaint has been adjudicated upon previousy and nothing has changed in the meantime, then the matter is referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. If, in the view of the Director, a compaint does not show that there may have been a breach of the Code, the compainant wi be so advised. If the compainant does not accept that view, the matter is referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. 5.3 When the compaint is from a pharmaceutica company, the compaint must be signed or authorized in writing by the company s managing director or chief executive or equivaent and must state those causes of the Code which are aeged to have been breached. A compaint from a pharmaceutica company wi be accepted ony if the Director is satisfied that the company concerned has previousy informed the company aeged to have breached the Code that it proposed to make a forma compaint and offered inter-company diaogue at a senior eve in an attempt to resove the matter, but that this offer was refused or diaogue proved unsuccessfu. A forma statement detaiing the actions taken must be provided. This requirement does not appy where the aegation is that a company has faied to compy with an undertaking that it has given and is in breach of Cause 29 of the Code. If, in the view of the Director, that condition has not been met, the compainant sha be so advised. If the compainant does not accept that view, the matter is referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. Attention is drawn to the avaiabiity of conciiation prior to making a compaint as referred to in Paragraph 18.2 beow. Information about conciiation is avaiabe from the Director. 5.4 Upon receipt of a compaint, the company concerned has ten working days in which to submit its comments in writing. 5.5 When the respondent company s response is received the case is referred to the Pane to determine whether or not there has been a breach of the Code. 5.6 When a company advises the Authority that it may have breached the Code, the Director wi treat the matter as a compaint. The company s response is invited. The case preparation manager may suggest the causes of the Code to be addressed. When the response is received the procedure under Paragraph 5.5 above wi be foowed. 5.7 The parties must be notified that a case has been referred to the Pane. 6 Compaints Arising from Media Criticism 6.1 When it appears to the Director from media reports (other than etters to the editor of a pubication) that a company may have breached the Code, the matter is treated as a compaint. The author of the artice, or the editor where no author is named, is treated as the compainant. The author, or editor, is asked if they want to be invoved in the case and whether they have any additiona information to submit. The consequences of not being invoved (no right of appea and no right to comment on a respondent s appea or the proposed text of the case report) must be expained in writing. If the author or editor decines invovement, this is stated in the case report. 46 CODE OF PRACTICE

48 6.2 A pubished etter from which it appears that a company may have breached the Code is deat with as a compaint with the author being treated as the compainant. The procedure set out in Paragraph 6.1 above wi be foowed. 7 Code of Practice Pane - Ruings 7.1 Where the Pane rues that there is a breach of the Code, the compainant and the respondent company are so advised in writing and are given the reasons for the decision. If the promotiona materia or activity at issue is considered by the Pane to be ikey to prejudice pubic heath and/or patient safety, and/or it represents a serious breach of the Code, the Pane must decide whether, if there is subsequenty an appea by the respondent company, it woud be required to suspend the use of the materia or activity pending the fina outcome of the case. If suspension woud be required, the company must be so notified when it is advised of the Pane s ruing of a breach of the Code. The respondent company has five working days to provide a written undertaking that the promotiona activity or use of the materia in question and any simiar materia (if not aready discontinued or no onger in use) wi cease forthwith and that a possibe steps wi be taken to avoid a simiar breach of the Code in the future. This undertaking must be signed by the managing director or chief executive or equivaent of the company or with his authority and must be accompanied by detais of the actions taken by the company to impement the undertaking, incuding the date on which the promotiona materia was finay used or appeared and/or the ast date on which the promotiona activity took pace. In exceptiona circumstances, an extension in the time aowed in which to respond may be granted at the discretion of the Director in accordance with Paragraph 14 beow. The company must aso pay within twenty working days an administrative charge based on the number of matters rued in breach of the Code. 7.2 Where the Pane rues that there is no breach of the Code, the compainant and the respondent company are so advised in writing and are given the reasons for the decision. Where the compaint is from a pharmaceutica company, the compainant must pay within twenty working days an administrative charge based on the number of matters aeged and rued not to be in breach of the Code. When advised of the outcome, the compainant wi be sent a copy of the comments and encosures submitted by the respondent company in reation to the compaint. If the respondent company objects to this because it regards part of the materia as being confidentia, and the matter cannot be setted by the Director, then it wi be referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. 7.3 The compainant or the respondent company may appea against a ruing of the Pane to the Appea Board. Appeas must be accompanied by reasons as to why the Pane's ruing is not accepted. These reasons wi be circuated to the Appea Board. Notice of appea must be given within five working days of notification of the Pane s ruing and the appea must be odged within ten days of notification of the Pane s ruing. If the Pane has so required in accordance with Paragraph 7.1 above, where the respondent company gives notice of appea it must, within five working days of notification of the Pane s ruing, suspend the use of the promotiona materia or activity at issue, pending the fina outcome of the case, and must notify the Authority that such action has been taken. If the respondent company accepts one or more of the Pane s ruings of breaches of the Code, but appeas one or more other such ruings, then within five working days of notification of the Pane s ruings it must provide the undertaking required by Paragraph 7.1 above in respect of the ruing or ruings which it is not appeaing. In exceptiona circumstances, an extension in the time aowed in which to respond may be granted at the discretion of the Director in accordance with Paragraph 14 beow. 7.4 Where an appea is odged by the compainant, the respondent company has five working days to comment on the reasons given by the compainant for the appea and these comments wi be circuated to the Appea Board. The compainant has five working days to comment on the respondent company s comments upon the reasons given by the compainant for the appea and these comments wi be circuated to the respondent company and the Appea Board. Reevant materia previousy submitted to the Pane is provided to the Appea Board. A additiona materia which the compainant and the respondent company want the Appea Board to consider must be submitted in writing with the appea, with the respondent company s comments on the reasons given by the compainant for the appea or with the compainant s comments on the respondent company s comments on the reasons given by the compainant for the appea. No new materia may be introduced when the appea is heard by the Appea Board. In the event that the respondent company objects to certain of its comments being made avaiabe to the compainant on the grounds of confidentiaity, and the matter cannot be setted by the Director, then it CODE OF PRACTICE 47

49 wi be referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, who wi determine whether those particuar comments can be incuded in the evidence which goes before the Appea Board. The referee s decision is fina. 7.5 Where an appea is odged by the respondent company, the compainant has five working days to comment on the reasons given by the respondent company for the appea and these comments wi be circuated to the respondent company and the Appea Board. Reevant materia previousy submitted to the Pane is provided to the Appea Board. A additiona materia which the compainant and the respondent company want the Appea Board to consider must be submitted in writing with the appea or with the compainant s comments on the reasons given by the respondent company for the appea. No new materia may be introduced when the appea is heard by the Appea Board. In the event that the respondent company objects to certain detais of its appea being made avaiabe to the compainant on the grounds of confidentiaity, and the matter cannot be setted by the Director, then it wi be referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, who wi determine whether those particuar detais can be incuded in the evidence which goes before the Appea Board. The referee s decision is fina. Where an appea is odged by the respondent company, the compainant is sent a copy of the initia comments and encosures submitted by the respondent company in reation to the compaint. If the respondent company objects to this because it regards part of the materia as being confidentia, and the matter cannot be setted by the Director, then it wi be referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. 7.6 Where the Pane rues no breach of the Code because it considers the matter of compaint is not within the scope of the Code the compainant and the respondent company are so advised in writing. When advised of the outcome, the compainant wi be sent a copy of the comments and encosures submitted by the respondent company in reation to the compaint. If the respondent company objects to this because it regards part of the materia as being confidentia, and the matter cannot be setted by the Director, then it wi be referred to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. The compainant may appea against the Pane s ruing to an independent referee identified by the Director and the Chairman of the Appea Board, for exampe a former independent member of the Appea Board, for his determination which is fina. An appea must be accompanied by reasons as to why the Pane s ruing is not accepted. These reasons wi be provided to the referee. The appea must be odged within ten working days of notification of the ruing of the Pane. The respondent company has five working days to comment on the reasons given by the compainant for the appea and these comments wi be provided to the referee. The compainant has five working days to comment on the respondent company s comments upon the reasons given by the compainant for the appea and these comments wi be provided to the respondent company and the referee. In the event that the respondent company objects to certain of its comments being made avaiabe to the compainant on the grounds of confidentiaity, and the matter cannot be setted by the Director, then the referee must decide whether he can take those comments into consideration when making his determination. In such an appea, the referee must consider no more than whether or not the matter of compaint is within the scope of the Code. If the referee determines that the matter is not within the scope of the Code the compainant and the respondent company are so advised in writing. If the referee determines that the matter is within the scope of the Code the compainant and the respondent company are so advised in writing. The case is referred back to the Pane for it to be considered on its merits and the procedure in Paragraph 5.5 above wi be foowed. No administrative charges appy in reation to proceedings under Paragraph 7.6 and there wi be no case reports. 8 Code of Practice Pane - Reports to the Code of Practice Appea Board 8.1 Faiure to compy with the procedures set out in Paragraphs 5 and 7 above wi be reported to the Appea Board. 8.2 The Pane may aso report to the Appea Board any company whose conduct in reation to the Code, or in reation to a particuar case before it, or because it repeatedy breaches the Code such that it raises concerns about the company s procedures, warrants consideration by the Appea Board. Such a report to the Appea Board may be made notwithstanding the fact that a company has provided an undertaking requested by the Pane. 48 CODE OF PRACTICE

50 9 Action on Compaints about Safety from the Medicines and Heathcare Products Reguatory Agency 9.1 In the event of the Medicines and Heathcare Products Reguatory Agency making a compaint which reates to the safety or proper use of a medicine, and requesting that an advertisement be withdrawn, the respondent company has five working days to respond with its comments. 9.2 If the Pane uphods the compaint, the company is required to suspend the advertisement or practice forthwith pending the fina outcome of the case. 10 Code of Practice Appea Board - Ruings 10.1 Where the Appea Board rues that there is no breach of the Code, the compainant and the respondent company are so advised in writing and are given the reasons for the decision. Where a compainant pharmaceutica company appeas and the Appea Board uphods the ruing that there is no breach of the Code, the compainant pharmaceutica company must pay within twenty working days an administrative charge based on the number of matters taken to appea on which no breach is rued. Where a respondent company appeas and the Appea Board rues that there is no breach of the Code, the compainant pharmaceutica company must pay within twenty working days an administrative charge based on the number of matters taken to appea on which no breach is rued Where the Appea Board rues that there is a breach of the Code, the respondent company is so advised in writing and is given the reasons for the decision. The respondent company then has five working days to provide a written undertaking providing reevant information as specified in Paragraph 7.1 above. The company must aso pay within twenty working days an administrative charge based on the number of matters rued in breach of the Code Where the Appea Board rues that there is a breach of the Code, it may require the company to take steps to recover items given in connection with the promotion of a medicine or non-promotiona items provided to heath professionas and members of the pubic and the ike. Written detais of the action taken must be provided to the Appea Board Where the Appea Board rues that there is a breach of the Code, it may require an audit of the company s procedures in reation to the Code to be carried out by the Authority and, foowing that audit, decide whether to impose requirements on the company concerned to improve its procedures in reation to the Code. These coud incude a further audit and/or a requirement that promotiona materia be submitted to the Authority for pre-vetting for a specified period. The Authority must arrange for materia submitted for pre-vetting to be examined for compiance with the Code but it cannot approve such materia. A of the costs of pre-vetting must be met by the company concerned. The Appea Board may aso require an audit if a company repeatedy breaches the Code Where the Appea Board rues that there is a breach of the Code, it may reprimand the company and pubish detais of that reprimand Where the Appea Board rues that there is a breach of the Code, it may require the company to issue a corrective statement. Detais of the proposed content and mode and timing of dissemination of the corrective statement must be provided to the Appea Board for approva prior to use. 11 Reports to the Code of Practice Appea Board 11.1 Where the Pane reports a company to the Appea Board under the provisions of Paragraphs 8.1 and 8.2 above, or where the Pane reports the faiure of a company to compy with the procedure set out in Paragraph 9 above, or where the Authority reports the faiure of a company to compy with the procedures set out in Paragraph 10 above, the procedures set out beow sha appy. These procedures aso appy if the Appea Board, having received a report on a case competed at the Pane eve, in accordance with Paragraph 4.1 above, considers that additiona sanctions may be appropriate The company concerned is provided with a copy of the report prior to its consideration and is entited to have a representative or representatives appear before the Appea Board to state the company s case. A company may not be represented before the Appea Board by a representative who is aso a member of the Appea Board except with the consent of the Chairman. Such consent may be given ony if the member of the Appea Board can satisfy the Chairman that no other person within his company can propery represent it in the matter in question The Appea Board may: reprimand the company and pubish detais of that reprimand require an audit of the company's procedures in reation to the Code to be carried out by the Authority and, foowing that audit, decide whether to impose requirements on the company concerned to improve its procedures in reation to the Code; these coud incude a further audit and/or a requirement that promotiona materia be submitted to the Authority for pre-vetting for a specified period; the Authority must arrange for materia submitted for pre-vetting to be examined for compiance with the Code but it cannot approve such materia; a of the costs of pre-vetting must be met by the company concerned CODE OF PRACTICE 49

51 require the company to issue a corrective statement; detais of the proposed content and mode and timing of dissemination of the corrective statement must be provided to the Appea Board for approva prior to use require the company to take steps to recover items given in connection with the promotion of a medicine or non-promotiona items provided to heath professionas and members of the pubic and the ike; written detais of the action taken must be provided to the Appea Board Where a company not in membership of the ABPI fais to compy with the procedures set out in Paragraphs 5, 7, 9 or 10 above and indicates that it no onger wishes to accept the jurisdiction of the Authority, the Appea Board may decide to remove the company from the ist of non member companies which have agreed to compy with the Code and advise the Medicines and Heathcare Products Reguatory Agency that responsibiity for that company under the Code can no onger be accepted. The ABPI Board must be advised that such action has been taken. 12 Code of Practice Appea Board - Reports to the ABPI Board of Management 12.1 Where the Appea Board considers that the conduct of a company in reation to the Code or a particuar case before it warrants such action, it may report the company to the ABPI Board. Such a report may be made notwithstanding the fact that the company has provided an undertaking requested by either the Pane or the Appea Board Where such a report is made to the ABPI Board, the ABPI Board may suspend or expe the company from the ABPI. In the case of a company not in membership of the ABPI, the ABPI Board may remove the company from the ist of non member companies which have agreed to compy with the Code and advise the Medicines and Heathcare Products Reguatory Agency that responsibiity for that company under the Code can no onger be accepted. To assist it in deciding whether to suspend or expe a company or, in the case of a company not in membership of the ABPI, to remove the company from the ist of non member companies which have agreed to compy with the Code, the ABPI Board may require an audit of the company s procedures in reation to the Code to be carried out by the Authority If a member of the ABPI Board is concerned in a case which has ed to the report, as either compainant or respondent, that member does not receive a copy of the report and is required to withdraw from the ABPI Board during its consideration. The company concerned is advised in advance of the membership of the ABPI Board and asked if it has any objections to particuar members and the grounds for such objections. Any member in respect of whom there are vaid objections must withdraw from the ABPI Board during consideration of the report. The President (or Chairman in the absence of the President) determines whether objections are vaid. Members of the ABPI Board must decare any other interest in a report prior to its consideration. Having consuted the company representative(s) (if present), the President (or Chairman in the absence of the President) determines whether it is appropriate for a particuar member to remain for the consideration of the report Where a report is made to the ABPI Board under Paragraph 12.1 above, the company concerned is provided with a copy of the report prior to its consideration and is entited to have a representative or representatives appear before the ABPI Board to state the company s case. 13 Case Reports 13.1 At the concusion of any case under the Code, the compainant is advised of the outcome and a report is pubished summarising the detais of the case The respondent company and the medicine concerned are named in the report. In a case where the compaint was initiated by a company or by an organisation or officia body, that company or organisation or officia body is named in the report. The information given must not, however, be such as to identify any individua. Where expert assistance has been obtained by either the Pane or the Appea Board, the report wi incude the name and quaifications of the expert concerned. Where a company has been required to issue a corrective statement, the report wi reproduce its text and provide detais of how the corrective statement was disseminated A copy of the report on a case is sent to both the compainant and the respondent company prior to pubication. Any amendments to the report suggested by these parties are considered by the Director, consuting with the other party where appropriate. If either party does not accept the Director's decision as to whether or not a report shoud be amended, the matter is referred to the Chairman of the Appea Board for his decision which is fina Copies of a case reports are submitted to the Appea Board prior to pubication. Copies of the reports are sent to the ABPI Board for information foowing pubication Fu case reports in printed form are pubished each quarter by the Authority. 50 CODE OF PRACTICE

52 Copies of the reports are sent to the Medicines and Heathcare Products Reguatory Agency, the Competition and Markets Authority, the Serious Fraud Office, the British Medica Association, the Roya Pharmaceutica Society, the Roya Coege of Nursing and the Editors of the BMJ, The Pharmaceutica Journa and the Nursing Standard. Copies are aso avaiabe to anyone on request In addition to the printed reports, fu case reports appear on the Authority s website. The website aso carries brief detais of a compaints which are currenty under consideration but not yet resoved and the texts and modes of dissemination of any corrective statements that companies have been required to issue during the previous tweve months. The Authority s website aso carries interim case reports in respect of cases where pubication of the fina report is deayed because either the Appea Board or the ABPI Board has required an audit of the respondent company s procedures in reation to the Code. Access to the Authority s website is unrestricted Foowing pubication of the reevant case reports, the Authority advertises in the medica, pharmaceutica and nursing press 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. Such advertisements aso appear on the Authority s website. The companies concerned are required to contribute to the cost of the press advertisements. GENERAL PROVISIONS 14 Time Periods for Responding to Matters under the Code The number of working days within which companies or compainants must respond to enquiries etc from the Authority, as referred to in the above procedures, is counted from the date of receipt of the notification in question. An extension in time to respond to such notifications may be granted at the discretion of the Director. 15 Withdrawa of Compaints and Notices of Appea 15.1 A compaint may be withdrawn by a compainant with the consent of the respondent company up unti such time as the respondent company s comments on the compaint have been received by the Authority, but not thereafter Notice of appea may be withdrawn by a compainant with the consent of the respondent company at any time but if notice is given by a compainant company after the papers reating to its appea have been circuated to the Appea Board, then the higher administrative charge wi be payabe Notice of appea may be withdrawn by a respondent company at any time but if notice is given after the papers reating to its appea have been circuated to the Appea Board, then the higher administrative charge wi be payabe. 16 Code of Practice Levy and Charges 16.1 An annua Code of Practice evy is paid by members of the ABPI. The evy together with the administrative charges referred to in Paragraphs 7 and 10 above, the charges for audits carried out in accordance with Paragraphs 10.4, 11.3 and 12.2 above and the contributions to the cost of press advertisements referred to in Paragraph 13.7 above are determined by the ABPI Board subject to approva at a Genera Meeting of the ABPI by a simpe majority of those present and voting Administrative charges are payabe ony by pharmaceutica companies and companies are iabe for such charges whether they are members of the ABPI or not. There are two eves of administrative charge. The ower eve is payabe by a company which accepts either a ruing of the Pane that it was in breach of the Code or a rejection by the Pane of its aegation against another company. The ower eve is aso payabe by a compainant company if a ruing of the Pane that there was a breach of the Code is subsequenty overturned by the Appea Board and by a respondent company if a ruing of the Pane that there was no breach of the Code is subsequenty overturned by the Appea Board. The higher eve is paid by a company which unsuccessfuy appeas a ruing of the Pane Where two or more companies are rued in breach of the Code in reation to a matter invoving copromotion, each company wi be separatey iabe to pay any administrative charge which is payabe Where a company advises the Authority that it may have breached the Code, and it is subsequenty rued in breach, any administrative charge payabe wi be one haf of that which woud otherwise have been due The number of administrative charges which appy in a case is determined by the Director. If a company does not agree with the Director s decision, the matter is referred to the Chairman of the Appea Board for his decision which is fina Faiure to pay any of the charges provided for by this paragraph must be reported by the Director to the Appea Board or the ABPI Board as appropriate. 17 Scrutiny 17.1 The Authority arranges for the scrutiny of sampes of advertisements, detai aids, eavepieces, other promotiona items and meetings on a continuing basis in reation to the requirements of the Code. CODE OF PRACTICE 51

53 Members of the Authority must not carry out scrutiny. To faciitate such scrutiny, the Director may request reevant materia from pharmaceutica companies, incuding copies of the certificates authorizing such materia, and companies must respond to such requests within ten working days Where a possibe breach of the Code is identified under this procedure by the scrutineer, the company concerned is requested to comment in writing within ten working days of receipt of the notification If the company accepts that there is a breach of the Code, the company is requested to provide an undertaking providing the information specified in Paragraph 7.1 above. No administrative charge wi be payabe in these circumstances and there wi be no case report on the matter in question If the company does not accept that there is a breach of the Code and, having considered the company s comments, the scrutineer decides that there is no case to answer under the Code, then the procedure is brought to a cose. There wi be no case report on the matter in question If the company does not accept that there is a breach of the Code but, having considered the company s comments, the scrutineer considers that a case has been estabished, the matter wi be deat with as a compaint. 18 Provision of Advice and Assistance with Conciiation 18.1 The Authority is wiing and abe to provide informa guidance and advice in reation to the requirements of the Code and, where appropriate, may seek the views of the Appea Board Companies wishing to seek the assistance of a conciiator with the view to reaching agreement on inter-company differences about promotion may contact the Director for advice and assistance. 19 Amendments to the Code of Practice and Constitution and Procedure 19.1 The Code and this Constitution and Procedure may be amended by a simpe majority of those present and voting at a Genera Meeting of the ABPI. Notwithstanding the above, where a proposa to amend the Code or this Constitution and Procedure arises soey from the ABPI s obigation to compy with any code promugated by the European Federation of Pharmaceutica Industries and Associations (EFPIA), then the ABPI Board may decide that forma approva at an ABPI Genera Meeting is not necessary. ABPI member companies must nonetheess be consuted in reation to the proposed texts of the changes The views of the Authority and the Appea Board must be sought on any proposa to amend the Code or this Constitution and Procedure. The views of the Medicines and Heathcare Products Reguatory Agency, the Competition and Markets Authority, the Serious Fraud Office, the British Medica Association, the Roya Pharmaceutica Society and the Roya Coege of Nursing must aso be invited. Notwithstanding the above, where the ABPI Board has decided, in accordance with Paragraph 19.1 above, that forma approva of the proposa at an ABPI Genera Meeting is not necessary, then the bodies referred to above need ony be informed of the changes which are to be made The Authority and the Appea Board may, in the ight of their experience, make recommendations for amendment of the Code and this Constitution and Procedure. 20 Annua Report An annua report of the Authority is pubished each year with the approva of the Appea Board. This report incudes detais of the work of the Authority, the Pane and the Appea Board during the year and provides a ist of a companies rued in breach of the Code during the year which specificay identifies those rued to have breached Cause CODE OF PRACTICE

54 GUIDELINES ON COMPANY PROCEDURES RELATING TO THE CODE OF PRACTICE Paragraphs 10.4, 11.3 and 12.2 of the Constitution and Procedure for the Prescription Medicines Code of Practice Authority variousy authorize the Code of Practice Appea Board or the Board of Management of the Association of the British Pharmaceutica Industry to require an audit of a company s procedures in reation to the Code of Practice for the Pharmaceutica Industry to be carried out by the Prescription Medicines Code of Practice Authority. Set out beow are guideines on company procedures which are regarded as representing good practice in this regard. They are minimum requirements and wi need to be adapted to fit in with the arrangements at any particuar company. Some of the changes made in the 2015 Code are mentioned in these guideines but companies shoud review the documentation sent out by the PMCPA in reation to the 2015 Code to ensure that they are fuy in compiance. In the 2015 Code, the term 'appropriate administrative staff has been repaced by 'other reevant decision makers', the atter being defined in Cause 1.5. It shoud be noted that Cause 19 and subsequent causes in the 2014 Code have been renumbered and, in some instances, rearranged, in the 2015 Code. The guideines do not cover a aspects of the Code and are thus no substitute for a detaied study of the Code as a whoe, incuding a of the suppementary information. 1) Scope of the Code It shoud be borne in mind that the Code covers some matters that are not necessariy reated to promotion. Companies shoud famiiarise themseves with the detai of what is covered and ensure that their procedures are such as to ensure compiance at a times. The suppementary information to Cause 1.1 gives guidance in this regard as does Cause 14.3 which detais materias to be certified even if they are non-promotiona in nature. Other materia issued by companies which reates to medicines but which is not intended as promotion for those medicines, such as corporate advertising, press reeases, market research materia, financia information for sharehoders and the Stock Exchange and responses to unsoicited enquiries from the pubic etc, shoud be examined to ensure that it does not contravene the Code or reevant statutory requirements. Account shoud be taken of the fact that nonpromotiona materia coud be used or made avaiabe in such a way that it woud be considered promotion and thereby come within the scope of the Code. 2) Co-Promotion Adequate provision shoud be made in copromotion agreements and the ike to ensure compiance with the Code. Where companies jointy promote the same product and the promotiona materia bears both company names, the companies concerned wi be hed jointy responsibe for it under the Code. As an aternative to each company separatey certifying joint materias, a change made in the 2015 Code aows the companies concerned to agree to have ony two fina signatories to certify on behaf of a of the companies. This must be agreed beforehand and the PMCPA and the MHRA notified in advance as to whom the signatories wi be. In the event of a compaint, each company concerned woud remain responsibe under the Code (suppementary information to Cause 14.1). 3) Breaches of the Code In the event of a company being found in breach of the Code, procedures shoud provide that adequate steps are taken to ensure that reevant information about the matter is communicated internay to appropriate members of staff. Procedures must be in pace to ensure that materia found to be in breach of the Code, and any simiar materia in any format, is quicky and entirey withdrawn from use, not forgetting materia stored eectronicay and/or in the hands of others, such as printers and agencies. It is important for the reputation of the industry that companies compy with undertakings. Inadequate action eading to a breach of undertaking is ikey to be in breach of Cause 2. Companies are advised to keep written records of the action taken to withdraw materia. 4) Compiance Companies shoud bear in mind that promotiona materia must be up-to-date at the time that it is sent or used or, in the case of a journa advertisement, at the pubication date of the journa. Each company must have a senior empoyee who is responsibe for ensuring that it meets the requirements of the Code (Cause 1.12). Uness other forma arrangements have been made by a company, it wi be assumed that the responsibe person is the managing director or chief executive or equivaent. To assist with compiance, companies shoud have a comprehensive set of standard operating procedures (SOPs) covering a aspects of the Code. CODE OF PRACTICE 53

55 SOPs shoud set out high standards and reevant staff shoud be trained and vaidated on their content. 5) Price Lists for Unicensed Medicines Price ists reating to unicensed medicines are aowed provided that they incude no product caims and make cear that the products are unicensed (Cause 1.2 and its suppementary information). Such price ists 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. 6) Advance Notification of New Products and Product Changes In the 2015 Code, the requirements have been amended to make it cearer that advance notification appies to products or changes which may significanty affect expenditure, which coud be significant additiona cost or significant savings. The 2015 Code states that wherever possibe information shoud be provided for incusion in nationa horizon scanning databases (suppementory information to Cause 3.1). 7) Prescribing Information In certain circumstances Cause 4 of the 2015 Code aows eements of the prescribing information to be provided by way of a copy of the summary of product characteristics. New suppementary information to Cause 4.4 in the 2015 Code covers the use of inks to prescribing information. Digita materia shoud provide a ink to prescribing information on another website ony where the materia is expected to be viewed onine, such as advertisements in eectronic journas. 8) Abbreviated Advertisements Abbreviated advertisements (Cause 5) must refer to a website where further information about the product can be found. This further information can consist of the prescribing information, as set out in Causes 4.2 and 4.3, or the summary of product characteristics. Cause 5.4 sets out the information which must be given. 9) Extremes of Format Extremes of format, size or cost of promotiona materia must be avoided (Cause 9.7). A informationa or educationa materias must be inexpensive, directy reevant to the practice of medicine or pharmacy and directy beneficia to the care of patients. 10) Cinica Trias Companies must discose detais of cinica trias (Cause 13.1). The suppementary information to Cause 13.1 detais how this shoud be done. Companies must incude, on the homepage of their website, information as to where detais of their cinica trias can be found. 11) Non-Interventiona Studies of Marketed Medicines A non-interventiona study of a marketed medicine is a study where the medicine is prescribed in the usua manner in accordance with the terms of its marketing authorization (Cause 13.2). The assignment of the patient to a particuar therapeutic strategy is not decided by a study protoco but fas within current practice and the prescription of the medicine is ceary separated from the decision to incude the patient in the study. No additiona diagnostic or monitoring procedures are appied to the patients and epidemioogica methods are used for the anaysis of coected data. A company invoved in non-interventiona studies must have a scientific service to dea with their approva and supervision as required by Cause Companies must pubish the summary detais and resuts of non-interventiona studies of marketed medicines competed on or after 1 May 2011 (Cause 13.3). This appies to studies with which a UK company has had any invovement. The 2008 Code encouraged companies to pubish this information and this sti appies to studies competed prior to 1 May Cause 13.4, which sets out the criteria with which non-interventiona studies must compy, appies to studies competed on or after 1 Juy 2008, though companies are encouraged to compy in reation to studies competed prior to that date. 12) Certification of Promotiona Materia Procedures must ensure that: promotiona materia is not issued unti its fina form has been certified in accordance with Cause 14 the names of signatories are notified in advance to the Advertising Standards Unit, Vigiance and Risk Management of Medicines of the Medicines and Heathcare Products Reguatory Agency and to the Prescription Medicines Code of Practice Authority (Cause 14.4) the form of certificate encompasses at east the requirements of Cause 14.5 materia sti in use is recertified at intervas of no more than two years (Cause 14.5); much more frequent recertification may be needed for some products and companies shoud ensure that the status of materia continuing in use is kept under review paper or eectronic copies of the certificates, together with the materia in the form certified and information as to whom it was addressed, the method of dissemination and the date of first dissemination are preserved for at east three years after fina use (Cause 14.6). 54 CODE OF PRACTICE

56 Each certificate shoud bear a reference number with the same reference number appearing on the promotiona materia in question so that there can be no doubt as to what has been certified. A particuar reference number shoud reate to ony one item of promotiona materia. Different sizes and different ayouts of a piece of promotiona materia shoud be separatey certified and each shoud have its own unique reference number. In the 2015 Code, the suppementary information to Cause 14.1 sets out a procedure to cover the situation where materia certified in an eectronic form is subsequenty printed. Any one of the company's signatories can check and sign the item in its fina printed form. There woud thus be two certificates and both must be preserved. 13) Certification of Representatives Briefing and Training Materias The certification requirements of Cause 14 appy aso to briefing materia prepared for representatives in accordance with Cause Briefing materia incudes the training materia used to instruct medica representatives about a medicine and the instructions given to them as to how the product shoud be promoted. Procedures must ensure that no such materia is used or issued prior to certification. 14) Certification of Items to be Passed on to Patients Items which are provided to heath professionas for them to pass on to patients must be certified (Causes 14.3 and 18.2). Such items must be part of a forma patient support programme, the detais of which must be appropriatey documented and certified in advance. 15) Certification of Other Materia Cause 14.3 ists other materia which needs to be certified and companies shoud famiiarise themseves with what is covered. Additionay, Cause 14.2 requires the certification of a meetings which invove trave outside the UK. This does not appy if the company s ony invovement is to support a speaker to present at the meeting. The Code now aows ony very imited provision to heath professionas of promotiona aids for them to keep and these must be certified (suppementary information to Cause 18.3 and Cause 14.1). 16) Representatives Expenses There shoud be a ceary aid down procedure for approva and payment of representatives expenses and expenditure on meetings and hospitaity and the ike. A system shoud be in pace for an audit on a systematic or random basis which wi check the nature of the expenditure which has been incurred and assess whether that expenditure was in accordance with the requirements of the Code. 17) Representatives Training Procedures must ensure that: representatives are aware that they must maintain a high standard of ethica conduct and compy with a reevant requirements of the Code (Cause 15.2) representatives (incuding contract representatives) are adequatey trained in reation to every product which they are to promote (Cause 15.1) representatives are not empoyed as medica representatives or generic saes representatives uness they have passed the reevant examination as provided for in Cause 16.3 or have been in such empoyment for ess than two years (whether continuous or otherwise and irrespective of whether with one company or with more than one company) contract representatives are ony empoyed or used if they compy with the requirements of Cause 16.3 as regards examination status. Representatives shoud be provided with written instructions on the appication of the Code to their work even if they are aso provided with an actua copy of it. It is recommended that each representative is given their own copy of the Code. Their instructions shoud cover such matters as the company s poicies on meetings and hospitaity, and the associated aowabe expenditure, and the specific requirements for representatives in Cause 15. It shoud be made cear how reporting to the scientific service of the company is to be carried out in reation to information about the medicines which they promote which comes to their notice, particuary reports of adverse reactions (Cause 15.6). It shoud be made cear to representatives as to whether, and in what circumstances, they can themseves write etters (or prepare other written materias) which mention particuar medicines and are thus amost certain to be considered promotiona materia. Such items must be certified, either in advance by way of proforma etters or by certifying each individua etter or other item, and must bear prescribing information in accordance with Cause ) Training It shoud be ensured that a reevant personne, incuding representatives, members of staff and others retained by way of contract, concerned in any way with the preparation or approva of promotiona materia or of information to be provided to members of the UK heath professions or to other reevant decision makers or of information to be provided to the pubic and recognised patient organisations, are fuy conversant with the requirements of the Code and reevant ega requirements (Cause 16.1). CODE OF PRACTICE 55

57 Appropriate arrangements shoud be in pace for training on the requirements of the Code. These may be interna arrangements for appropriate staff members but it is recommended that key personne attend one of the seminars organised by the Prescription Medicines Code of Practice Authority. A personne (and others retained by way of contract) must be fuy conversant with pharmacovigiance requirements reevant to their work and this must be documented (Cause 16.2). Adequate arrangements shoud be in pace to ensure that any information as to changes to the Code etc, incuding reports of decided cases, are circuated to reevant personne. Companies shoud consider making knowedge of, and compiance with, their obigations in reation to both the Code and pharmacovigiance requirements part of the annua appraisa process for reevant empoyees. Cause 16.3 sets out the requirements reating to the need for representatives to pass an appropriate examination. Examination status is enquired into when a compaint is received about a representative. Companies shoud have appropriate procedures in pace to ensure that representatives enter for the examination on the eariest practicabe date. Representatives must take the examination in their first year of such empoyment and must pass it within two years of starting such empoyment. A significant change made in the 2014 Code was that the examinations woud in due course have to be accredited to at east Leve 3 by an externa awarding body recognised by Ofqua. The ABPI is now offering accredited examinations and wi cease to offer its unaccredited examinations at the end of Examinations may aso be offered by providers other than the ABPI (Cause 16.3). Representatives commencing such empoyment on or after 1 October 2014 must take an accredited examination. It is recommended that representatives commencing such empoyment on or after 1 January 2014 but on or before 30 September 2014 aso take an accredited examination. There is more detai in the suppementary information to Cause ) Provision of Medicines and Sampes Companies shoud ensure that their procedures are such as to ensure compiance with Cause 17. They shoud be cear as to the distinctions between sampes, identification sampes, titration packs and free goods etc which are described in the suppementary information to Cause 17. Eectronic signatures are acceptabe in reation to requests for sampes. Not more than four sampes of a particuar medicine may be provided to an individua heath professiona during the course of a year (Cause 17.2). Sampes of a medicine can be provided to a heath professiona for ony two years after that heath professiona first requests sampes of it. There is a specia provision for the samping of new medicines which are extensions of existing medicines (Cause 17.2). Medicines covered by Cause 17.6 cannot be provided as sampes at a. Cause 17.9 requires companies to have adequate systems of contro and accountabiity for sampes and for a medicines handed by representatives. Simiary, there shoud be an adequate system to contro the number of sampes of a particuar product given to a particuar heath professiona (Cause 17.2). Sampes must not be given for the soe purpose of treating patients (Cause 17.12). Starter packs are not permitted (suppementary information to Cause 17). Starter packs were sma packs designed to provide sufficient medicine for a primary care prescriber to initiate treatment in such circumstances as a ca out in the night. 20) Items for Patients and Promotiona Aids The traditiona forms of promotiona aid, such as coffee mugs, stationery and caendars, cannot be given to heath professionas and nor can items for use in a cinic or treatment room, such as surgica goves, tongue depressors, tissues and the ike (suppementary information to Cause 18.1). Toys and puzzes for chidren to pay with cannot be provided either. Items intended to be passed on to patients can be provided to heath professionas if these are part of a patient support programme, the detais of which have been appropriatey documented and certified in advance (Cause 18.2). They must cost no more than 6, excuding VAT, and the perceived vaue to the heath professiona and the patient must be simiar. They must directy benefit patient care. Such items can be provided to heath professionas by representatives during the course of a promotiona ca but they must not be given out from exhibition stands. In imited circumstances, patient support items can be provided to heath professionas when they are not to be passed to patients for them to keep (suppementary information to Cause 18.2). This is where their purpose is to aow patients to gain experience in using their medicines whist under the supervision of a heath professiona. Exampes are inhaation devices devoid of active ingredients and devices to assist patients to earn how to sef- inject. 56 CODE OF PRACTICE

58 The ony items that can be provided to heath professionas for them to keep are notebooks, pens and pencis for use at bona fide meetings and conferences etc. No individua shoud receive more than one notebook and one pen or penci. The tota cost of such items provided to an individua must not exceed 6, excuding VAT, and the perceived vaue to the recipient must be simiar. They must not bear the name of a medicine or any information about medicines but may bear the name of the company providing them (Cause 18.3). They must not be provided by representatives when caing upon heath professionas. They must not be given out from exhibition stands. They can be incuded in conference bags at third party meetings but cannot then bear the name of the company providing them. Memory sticks and DVDs provided in accordance with the suppementary information to Cause 18.1 must be inexpensive. There is much detai in the suppementary information to Causes 18.1, 18.2 and 18.3 and it is essentia that companies famiiarise themseves with it. 21) Medica and Educationa Goods and Services The provision of medica and education goods and services must be carried out in compiance with Cause 19 and must be certified in accordance with Cause There is much detai in the suppementary information to Cause ) Joint Working, Outcome Agreements, Patient Access Schemes and Package Deas Joint working between the NHS and the pharmaceutica industry is deat with in the Code in some detai (Cause 20). An executive summary of a joint working agreement must be made pubic in reation to joint working projects starting on or after 1 May 2011 or on-going on that date. Materia reating to joint working must be certified (Cause 14.3). The Code requires pubic discosure of transfers of vaue in connection with joint working. This appies to transfers of vaue made in 2015 and each caendar year thereafter (Cause 20). Discosure of 2015 data wi be required in Cause 24 sets out the requirements in reation to transfers of vaue. The suppementary information to Cause 18.1 deas with outcome or risk sharing agreements, patient access schemes and package deas. 23) Donations and Grants to Institutions, Organisations and Associations Cause 18.6 of the 2011 Code required pharmaceutica companies to make pubicy avaiabe detais of grants and donations made to institutions, organisations and associations. This appied to donations and grants made in 2012 and each caendar year thereafter. The 2014 Code introduced requirements for pubic discosure which differred from those in the Second 2012 Code. The new requirements appy to transfers of vaue made in 2015 and each caendar year thereafter. Discosure of 2015 data wi be required in Cause 24 sets out the requirements in reation to transfers of vaue. For discosures in reation to caendar years 2013 and 2014, the requirements and procedures in Cause 18.6 and its suppementary information in the Second 2012 Edition of the Code continue to appy. The Code now requires pubic discosure of transfers of vaue in reation to contracts under which institutions etc provide services to pharmaceutica companies (Cause 21 and its suppementary information). This wi appy to data for 2015 and each caendar year thereafter. Discosure must be carried out in accordance with Cause ) Meetings and Hospitaity A company must have a written document that sets out its poicies on meetings and hospitaity and the associated aowabe expenditure and must ensure that a meetings that it pans are checked to see that they compy with Cause 22. Cause 22.2 stipuates that the cost of a mea (incuding drinks) provided by way of subsistence must not exceed 75 per person excuding VAT and gratuities. The suppementary information to Cause 22.2 sets out futher detais. The maximum of 75 pus VAT and gratuities does not appy to meetings hed in european countries where the nationa association is a member of EFPIA. The oca imit woud appy instead. Information is avaiabe at EFPIA.eu. Meetings hed outside the UK are not necessariy unacceptabe but there have to be vaid and cogent reasons for the use of a venue outside the UK (suppementary information to Cause 22.1). Meetings which invove trave outside the UK must be formay certified as set out in Cause This does not appy if the company s ony invovement is to support a speaker to present at the meeting. A company s procedures shoud cover its own meetings, those which it sponsors and the sponsorship of attendance at meetings. Companies shoud remind their affiiates that the ABPI Code of Practice must be compied with if UK heath professionas attend meetings which they organise regardess of whether such meetings occur in the UK or abroad. 25) Sponsorship to Attend Meetings The 2011 Code required financia detais of sponsorship of UK heath professionas and appropriate administrative staff to attend meetings organised by third parties to be made pubicy avaiabe. CODE OF PRACTICE 57

59 The information had to be made pubicy avaiabe in respect of sponsorship to attend meetings in 2012 and each caendar year thereafter. The 2014 Code introduced different requirements which appied to both meetings organised by third parties and those organised by pharmaceutica companies. The previous requirements in the Second 2012 Code appied ony to meetings organised by third parties. Discosure wi be of attendance at meetings in 2015 and each caendar year thereafter. Discosure of 2015 data wi be required in 2016 (Cause 22.5 and its suppementary information). Discosure must be carried out in accordance with Cause 24. For discosure in reation to caendar years 2013 and 2014 the requirements and procedures in Cause 19.4 and its suppementary information in the Second 2012 Edition of the Code sti appy. 26) The Use of Consutants Heath professionas and other reevant decision makers may be used as consutants and advisors for services such as speaking at and chairing meetings, invovement in medica/scientific studies, cinica trias or training services, participation at advisory board meetings, and participation in market research where such participation invoves remuneration and/or trave. The arrangements which cover these genuine consutancy or other services must, to the extent reevant to the particuar arrangement, fufi the criteria set out in Cause 23 and procedures shoud ensure that the requirements of that cause are compied with. Changes were made in reation to the use of consutants in the 2011 Code. In particuar, pubic discosure of fees paid to consutants in the UK for certain services woud be required for payments made in 2012 and each caendar year thereafter (Cause 20.2). No discosure was required in reation to payments for research and deveopment work, incuding the conduct of cinica trias. Additiona information woud have to be discosed in reation to certain payments made in 2013 and each caendar year thereafter (Cause 20.3). The 2014 Code made significant changes in reation to transfers of vaue to consutants. Transfers of vaue in reation to research and deveopment work (incuding the conduct of cinica trias) were now incuded but were to be discosed on an aggregate basis. The new requirements appy to data for 2015 and each caendar year thereafter. The data for 2015 wi be discosed in Discosure must be carried out in accordance with Cause 24. There is much detai in the suppementary information to Causes 23.2 and For discosures in reation to caendar years 2013 and 2014, the requirements and procedures in Causes 20.2 and 20.3 and their suppementary information in the Second 2012 Edition of the Code sti appy. Contracts or agreements with consutants entered into or renewed on and after 1 May 2011 must incude provisions regarding their obigation to decare the arrangement whenever they write or speak in pubic about the subject of the agreement or any issue reating to the company (Cause 23.1). Companies are encouraged to renegotiate existing contracts to incude such provisions at their eariest convenience. 27) Transfers of vaue Transfers of vaue to heath professionas and heathcare organisations must be discosed (Cause 24). The term transfer of vaue is defined in Cause 1.10 and the suppementary information to Cause 1.10 ists a number of matters which are not transfers of vaue for the purposes of the Code. Cause 24.2 ists transfers of vaue covered by Cause Transfers of vaue to patient organisations are not covered by Cause 24. These transfers of vaue continue to be covered by Causes 27.7 and The matter is compicated as far as the Code is concerned by the fact that it aready had discosure requirements, some of which wi be superseded in due course by the new requirements which are derived from the new EFPIA Code on Discosure of Transfers of Vaue from Pharmaceutica Companies to Heathcare Professionas and Heathcare Organisations. The new requirements invove the discosure of 2015 data in The existing requirements reate to the discosure of 2012 and 2013 data onwards and these requirements wi continue to appy unti the new requirements supersede them. References to the new requirements are made at reevant paces in these Guideines. Discosures must be made in accordance with Cause 24. Companies must discose using the centra UK patform and a standard tempate (suppementary information to Cause 24.1). Companies shoud take steps to ensure that they wi be abe to readiy source the information to be pubicy discosed. 28) Scientific Services Companies must ensure that they have an identifiabe scientific service to compie and coate a information, from medica representatives or any other source, about the medicines which they market (Cause 25.1). Where reevant, they must aso have a scientific service to dea with the approva and supervision of non-interventiona studies (Cause 25.2). There can be one scientific service in charge of both responsibiities or separate services with ceary deineated duties. 58 CODE OF PRACTICE

60 29) Reations with the Pubic and the Media Prescription ony medicines must not be advertised to the pubic but information about them can be provided either directy or indirecty. The provision of information to the pubic about prescription ony medicines must be in accordance with Cause 26. Any materia which reates to a medicine and which is intended for patients taking that medicine must incude a statement reating to the reporting of side effects. If the medicine is one which is subject to additiona monitoring, then the materia must incude an inverted back equiatera triange and an additiona statement (Cause 26.3). 30) Reationships with Patient Organisations Pharmaceutica companies can interact with patient organisations or any user organisation such as disabiity organisations, carer or reative organisations and consumer organisations to support their work, incuding assistance in the provision of appropriate information to the pubic, patients and carers (Cause 27). When working with patient organisations, companies must ensure that a of the arrangements compy with the Code. This incudes the prohibition on advertising prescription ony medicines to the pubic (Cause 26.1). The requirements of Cause 22, which covers meetings for heath professionas and other reevant decision makers, aso appy to pharmaceutica companies supporting patient organisation meetings. A ist of patient organisations that have been engaged to provide significant contracted services must be pubished and updated at east once a year. Companies shoud ensure that such contracts compy with the criteria in Cause Hospitaity can be provided in certain circumstances to patient carers (suppementary information to Cause 27.2). 31) The Internet Companies shoud ensure that a reevant requirements of the Code, incuding Cause 28, are compied with in reation to promotiona materia for prescription ony medicines which is provided on the Internet and directed to a UK audience. If access to such materia is not imited to heath professionas and other reevant decision makers, a pharmaceutica company website or a company sponsored website must provide information for the pubic as we as promotion to heath professionas with the sections ceary separated and the intended audiences identified. Materia intended for the pubic which is provided on the Internet must compy with Cause Companies must ensure that the requirements of Cause 27 are compied with when working with patient organisations. In particuar, written agreements must be in pace in respect of every significant activity or ongoing reationship (Cause 27.3) and there has to be pubic discosure of financia support or indirect/non financia support. The pubished information must incude the monetary vaue of financia support and of invoiced costs (Cause 27.7). For significant non-financia support that cannot be assigned a meaningfu monetary vaue, the pubished information must describe ceary the non-monetary vaue that the organisation receives. Companies must ensure that their support is ceary acknowedged from the outset. The wording of a decaration of sponsorship must accuratey refect the nature of a company s invovement. Contracts under which patient organisations provide consutancy or other services to companies are subject to the Code and Cause 27.8 specifies the criteria which contracts for such services must meet, to the extent reevant to the particuar arrangement. CODE OF PRACTICE 59

61 LEGISLATION, OTHER CODES and GUIDELINES LEGISLATION The Human Medicines Reguations No The Human Medicines (Amendment) (No.2) Reguations 2014 No The Consumer Protection from Unfair Trading Reguations No Directive 2001/83/EC on the Community Code reating to medicina products for human use, as amended by Directive 2004/27/EC Bribery Act 2010 OTHER CODES Internationa IFPMA Code of Practice (Internationa Federation of Pharmaceutica Manufacturers and Associations) EFPIA Code on the Promotion of Prescription-Ony Medicines to, and Interactions with, Heathcare Professionas EFPIA Code of Practice on Reationships between the Pharmaceutica Industry and Patient Organisations EFPIA Code on Discosure of Transfers of Vaue from Pharmaceutica Companies to Heathcare Professionas and Heathcare Organisations (European Federation of Pharmaceutica Industries and Associations EFPIA) WHO Ethica Criteria for Medicina Drug Promotion, Geneva 1988 (Word Heath Organisation) IPCAA Heathcare Congress Guideines (Internationa Pharmaceutica Congress Advisory Association) United Kingdom The UK Code of Non-broadcast Advertising, Saes Promotion and Direct Marketing (Committee of Advertising Practice/Advertising Standards Authority) Codes of Practice for Advertising Over-the-Counter Medicines the PAGB Consumer Code and the PAGB Professiona Code (Proprietary Association of Great Britain PAGB) BMA Medica ethics today (British Medica Association) Genera Medica Counci Good Medica Practice Genera Pharmaceutica Counci Standards of conduct, ethics and performance Nursing & Midwifery Counci Standards of conduct, performance and ethics for nurses and midwives Department of Heath Commercia sponsorship Ethica standards for the NHS Department of Heath Standards of Business Conduct for NHS Staff GUIDELINES Advertising and Promotion of Medicines in the UK (2014) The Bue Guide (Medicines and Heathcare Products ReguatoryAgency). It incudes Disease Awareness Campaigns Guideines and Medicines which are promoted for use during pregnancy Guidance for the pharmaceutica industry Best practice guidance on joint working between the NHS and the pharmaceutica industry and other reevant commercia organisations (Department of Heath) Moving beyond sponsorship: interactive tookit for joint working between the NHS and the pharmaceutica industry (Department of Heath/ABPI) ABPI Guidance notes on joint working between pharmaceutica companies and the NHS and others for the benefit of patients Joint Position on the Discosure of Cinica Tria Information via Cinica Tria Registries and Databases 2009 ( Joint Position on the Pubication of Cinica Tria Resuts in the Scientific Literature 2010 ( Guideines on Standards in Medica Information (Pharmaceutica Information & Pharmacovigiance Association) The Lega & Ethica Guideines for Heathcare Market Research (British Heathcare Business Inteigence Association/ABPI) PMCPA GUIDANCE NOTES Guidance about Certification (incuding certification of muti company projects) Guidance about Cause 3 Guidance about Digita Communications 60 CODE OF PRACTICE

62 INDEX Key numbers refer to causes in the Code si refers to suppementary information to a cause in the Code foowed by number refers to a paragraph in the Constitution and Procedure abbreviated advertisements 5 ABPI (the Association of the British Pharmaceutica Industry) Board of Management 1.3, 3.1, 11.4, 12, 13.4, 16.1 & 16.6 examinations 16.3 & si absoute risk, reference to si to 7.2 administrative charges appeas against number of 16.5 determination of charges in cases 16.5 in reation to admissions 16.4 in co-promotion 16.3 eves of 16.2 faiure to pay 16.6 payment of in reation to ruings by Appea Board 10.1 & 10.2 by Pane 7.1 & 7.2 administrative staff, promotion to si to 1.1 admissions by pharmaceutica companies 5.6 & 16.4 advance notification of new products si to 3.1 adverse reactions caims about 7.9 need to consut SPC 4.2 & 5.4 references to in prescribing information 4.2 reporting mechanisms 4.10 & si, 5.6 & si advertising to the pubic 1.1 & 26.1 & si advice on Code 18.1 a-embracing caims 7.10 & si amendments to Code and Constitution and Procedure 19 amount of advertising in journas 6 & si anima data, use of si to 7.2 appeas against Pane ruings appeas by compainants 7.3 & 7.4 appeas by respondent companies 7.3 & 7.5 appearance before Appea Board 4.6 withdrawa of appeas 15 approva of promotiona materia see certification artwork, iustrations, graphs and tabes genera 7.8 abbreviated advertisements si to 5.4, 5.5, 5.6, 5.7, 5.8 & 5.9 references to sources when taken from pubished studies 7.8 & si see aso si to 7.2 on use of statistica information audio-visua materia and interactive data systems etc abbreviated advertisements not permitted 5.2 certification si to 14.1 prescribing information requirements 4.4 & si, 4.5 & si & 4.6 audit of company s procedures 10.4, 11.3 & 12.2 charges for 16.1 automated caing systems 9.9 benefit/risk profie si to 7.10 benefits 18.1 & si & 19.1 & 19.2 & si back triange symbo 4.11 & si and si to 4.1 in abbreviated advertisements 5.7 & si in materia intended for patients 26.3 & si Bue Guide si to 1.1 & 28.1, 28.4 & 28.5 & page 60 bonus stock see sampes si to 17 brand names, use of other companies si to 7.3 Bribery Act page 60 briefing materia for representatives 15.9 & si British Medica Association case reports 13.5 consutation with on appointment of Appea Board independent registered medica practitioners 3.2 on Code 19.2 Medica Ethics Today page 60 carers, hospitaity to si to 27.2 case preparation manager 2.1, 5.1, 5.2, & 5.6 case reports 13 centra patform for discosure of transfers of vaue si to 24.1 certification genera 14 audio and audio-visua materia etc si to 14.1 content of certificate 14.5 educationa materia reating to diseases or medicines 14.3 Internet si to 14.1 joint working materia 14.3 meetings hed outside UK 14.2 non-promotiona materia reating to the provision of medica and educationa goods and services 14.3 notification of signatories 14.4 patient organisation materia 14.3 patient support programme materia 14.3 preservation of certificates 14.6 & si promotiona aids si to 14.1 promotiona materia 14.1 CODE OF PRACTICE 61

63 promotiona materia at internationa conferences in UK si to 3 quaifications and experience of signatories 14.1 & si chidren in advertisements si to 7.8 cinica assessments 12.2 cinica and scientific opinion current views of authors 10.4 & si disparaging cinica and scientific opinion 8.2 emerging opinion si to 7.2 cinica trias, discosure of detais 13.1 & si cinica tria data, use of si to 7.5 Codes of Practice for Advertising Over-the-Counter Medicines of the PAGB page 60 Code of Practice Appea Board Constitution and Procedure 3 & 4 independent members to be in a majority 4.2 membership 3.2 power to pubicy reprimand 10.5 & 11.3 power to require audit 10.4 & 11.3 power to require a corrective statement 10.6 & 11.3 power to require pre-vetting 10.4 & 11.3 power to require recovery of items 10.3 & 11.3 reports from Code of Practice Pane 4.1 & 8 reports to ABPI Board 12.1 reports to, consideration of 11 ruings 10 Code of Practice evy 16.1 Code of Practice Pane Constitution and Procedure 2 membership 2.1 power to suspend advertising on compaints from Medicines and Heathcare Products Reguatory Agency 9.2 power to suspend materia or activities in certain circumstances pending an appea 7.1 reports to Appea Board 4.1 & 8 ruings 7 Commission on Human Medicines, Medicines and Heathcare Products Reguatory Agency and icensing authority, references to 9.5 & si comparisons genera 7.2 & 7.3 & si disparaging references, prohibition on 8.1 & si hanging comparisons si to 7.2 price/cost comparisons si to 7.2 competitions & quizzes si to 18.1 Competition and Markets Authority consutation with on Code 19.2 compaints procedure compaints from Medicines and Heathcare Products Reguatory Agency 9 confidentiaity of compainants see introduction to Constitution and Procedure page 42 deaing with compaints 5 to 13 making compaints genera see introduction to Constitution and Procedure page 42 by pharmaceutica companies 5.3 withdrawa of compaints 15 conciiation between companies 18.2 conferences see meetings confidence in the industry 2 & si consutants discosure of payments to 23.2 & 23.3 & si from patient organisations 27.8 & si use of 23 & si continuing professiona deveopment meetings and courses si to 22.1 contracts with institutions etc 21 co-promotion si to 14.1 corporate advertising, examination of si to 14.3 cost comparisons si to 7.2 criticism in media 6 current views of authors 10.4 & si data on fie, provision of 7.7 date of prescribing information 4.2 date of promotiona materia 4.9 deivery of items by representatives si to 15.3 discounts see trade practices discredit to the industry 2 & si disease awareness campaigns si to 26.2 Disease Awareness Campaigns Guideines si to 26.2 & page 60 disguised promotion 12 & si disparaging references, prohibition on 8 & si distribution of promotiona materia 11 & si doctors, use of names and photographs 9.3 donations in ieu of hospitaity si to 15.3 to charities si to 15.3 & 18.1 to institutions etc 19.1 & 19.2 & si see aso prohibition on financia inducements 18.1 DVDs for heath professessionas si to 18.1 dynamic content for websites si to 14.1 economic evauation of medicines si to 7.2 educationa goods and services, provision of 19.1 & 19.2 & si 62 CODE OF PRACTICE

64 EFPIA Code on the Promotion of Prescription Ony Medicines to, and Interactions with, Heathcare Professionas see introduction to Code & page 60 EFPIA Code of Practice on Reationships between the Pharmaceutica Industry and Patient Organisations see introduction to Code & page 60 EFPIA Code on Discosure of Transfers of Vaue by Pharmaceutica Companies to Heathcare Professionas and Heathcare Organisations see introduction to Code & page 60 eectronic data communications 9.9 emai, use of 9.9 & si & si to 15 emoticons, use of si to 9.1 & 9.2 empoyee responsibe for ensuring compiance with Code 1.12 & si empoyees, current and prospective, information for si to 26.2 Europe definition of term si to 24.1 European Directive see introduction to Code & page 60 exaggerated or a-embracing caims 7.10 & si examinations for representatives 16.3 to 16.4 & si exhibitions and exhibition panes, prescribing information requirements si to 4.1 experience programmes 12.2 extremes of format, size & cost of promotiona materia 9.7 & si see aso si to 11.2 facsimie, use of 9.9 & si to 15 fims see audio-visua materia and interactive data systems etc financia inducements, prohibition of 18.1 free goods see sampes si to 17 frequency of maiings 11.2 & si of maiings for new medicines si to 11.2 of cas by representatives 15.4 & si Genera Medica Counci si to 15.3, 18.1 & 22.1 & page 60 Genera Pharmaceutica Counci si to 15.3, 18.1 & 22.1 & page 60 gifts 18.1 & si grants to institutions etc 19.1 & 19.2 & si graphs see artwork, iustrations, graphs and tabes guideines on company procedures reating to the Code of Practice page 53 hanging comparisons si to 7.2 heath professionas, use of names and photographs 9.3 heath professions, criticism of 8.2 heathcare organisation definition of term 1.9 & si heathy vounteer studies, use of data from si to 7.2 high standards, maintenance of 9.1 hospitaity 22 imit on cost of mea 22.2 & si Human Medicines Reguations see introduction to Code & page 60 IFPMA Code of Practice see introduction to Code & page 60 iustrations see artwork, iustrations, graphs and tabes inducements 18.1 information to the pubic 26 & si, 28 & si inserts in journas cannot be abbreviated advertisements 5.2 size of 6.2 see aso si to 6.3 interactive data systems see audio-visua materia and interactive data systems etc internationa conferences, symposia and meetings see meetings internationa journas, advertising in si to 1.1 Internet genera 28 abbreviated advertisements not permitted 5.2 access to promotiona materia by pubic si to 28.1 certification si to 14.1 journas 28.4 prescribing information requirements 4.6 in-vitro data, use of si to 7.2 items deivered by representatives si to 15.3 joint ventures & co-promotion si to 14.1 joint working with the NHS si to 1.1 & 20 & si journa advertising advertising in internationa journas si to 1.1 specific requirements 4.7 & 6 see aso abbreviated advertisements in professiona pubications 5.2 & si knocking copy 8.1 & si see aso 7.3 abeing abeing of medicines 1.2 under It does not incude abeing of sampes 17.5 egisation page 60 evy faiure to pay 16.6 eve of 16.1 icensing authority, references to 9.5 imitations on journa advertising 6 & si CODE OF PRACTICE 63

65 inks to prescribing information 4.4 & si oans,ong term or permanent si to 18.1 maiings frequency and number of 11.2 & si maied medicines maiing ists 11.3 margins see trade practices market extension si to 1.1 market research discosure of payments 23.1 & si 23.3 & si genera 12.2 & si guideines The Lega & Ethica Guideines for Heathcare Market Research si to 12.2 & page 60 market share caims si to 7 marketing authorization 3 & si meas imit on cost 22.2 & si media compaints arising from 6 reations with 26 & si medica and educationa goods and services, provision of 19 & si medicines distributed in hospitas 17.8 handed by representatives 17.9 posted Medicines and Heathcare Products Reguatory Agency case reports 13.5 compaints from 9 consutation with on appointment of Appea Board independent members 3.1 on Code 19.2 Disease Awareness Campaigns Guideines si to 26.2 & page 60 MHRA Drug Safety Update si to 9.5 references to 9.5 & si submission of briefing materia 15.9 submission of certificates 14.6 submission of names of signatories for promotiona materia 14.4 The Bue Guide Advertising and Promotion of Medicines in the UK si to 1.1, 28.1, 28.4 & 28.5 & page 60 meetings genera 22 attendance by administrative staff si to 22.1 certification of meetings hed outside the UK 14.2 continuing professiona deveopment (CPD) meetings and courses si to 22.1 exhibitions and exhibition panes, prescribing information requirements si to 4.1 hed outside the UK si to 22.1, certification of 14.2 hospitaity, provision of 22.1 & si invoving trave outside the UK si to 22.1, certification of 14.2 organised by affiiates si to 22.1 payment of room renta 22.3 & si payment of traveing and accommodation expenses 22 & si prohibition on inducements and payments for interviews 15.3 & 18.1 & si promotion at internationa meetings si to 3 & 22.1, see aso si to 1.1 reports on meetings si to 22.4, see aso 10.3 sponsorship of attendance at meetings, discosure of 22.5 & si sponsorship of meetings, discosure of 22.4 & si subsistence, provision of 22.1 & si venue, suitabiity of 22.1 & si membership of Code of Practice Appea Board 3.2 of Code of Practice Pane 2.1 memory sticks for heath professionas - si to 18.1 MHRA Drug Safety Update - si to 9.5 naked or partiay naked peope, use of in advertising si to 9.1 & 9.2 Nationa Heath Service, joint working with si to 1.1 & 20 & si new medicines advance notification of new products si to 3.1 avoidance of extremes of format, size or cost si to 9.7 introduction of a new medicine 26.5 imitations on maiings 11.2 & si use of the word new 7.11 non - interventiona studies of marketed medicines approva and supervision of 25.2 discosure of 13.3 & si genera 13.2 to 13.4 & si non-proprietary name, size and position 4.3 & 5.5 Nursing & Midwifery Counci Standards of conduct, performance and ethics for nurses and midwives si to 15.3, 18.1, 18.4 & 22.1 & page 60 offence, causing 9.2 officia documents, reproduction of 9.6 other reevant decision makers definition of term 1.5 outcome agreements si to 18.1 over-the-counter medicines definition of term 1.6 scope of the Code 1.1 & si package deas si to 18.1 package eafets 1.2 under it does not incude on the Internet 28.5 provision to the pubic si to 26.2 & 28.5 patient access schemes si to 18.1 patient carers, hospitaity to si to 27.2 patient information eafets provision by doctors to patients 26.2 & 26.3 & si see aso package eafets patient organisations reationships with 27 & si 64 CODE OF PRACTICE

66 discosure of support 27.7 & si services provided by 27.8 & si patients, items given to 18.2 & si patient support items 18.2 & si payments for interviews 15.3 & si & 18.1 & si pecuniary advantage, offer or provision of 18.1 & si pharmacovigiance personne s knowedge of 16.2 PMCPA guidance notes page 60 post - authorization studies 12.2 & 13 postcards, use of 9.8 posted medicines post-marketing surveiance studies 12.2 & 13 potency per weight caims si to 7.2 pre-printed private prescription forms si to 9.1 & 9.2 prescribing information genera 4 date of 4.2 exemptions 4.1 & 5.1 egibiity 4.1 & si provision on audio-visua etc 4.5 & si exhibitions and exhibition panes si to 4.1 Internet 4.6 journa advertisements 4.7 muti-page advertisements other than journa advertisements 4.8 requisite information 4.2 size of non-proprietary name 4.3 typesize si to 4.1 prescription forms pre-printed private prescription forms si to 9.1 & 9.2 reproduction of officia documents 9.6 Prescription Medicines Code of Practice Authority annua report 20 materia to be suppied to Authority authority of Director to require materia 1.4 copies of certificates 14.6 examination status of representatives 16.4 materia required for scrutiny 17.1 medica representatives briefing materia 15.9 names of signatories 14.4 scrutiny 17 structure and responsibiities 1 press conferences and press announcements 26.2 & si pre-vetting cost of 10.4 & 11.3 power of Appea Board to require 10.4 & 11.3 price comparisons si to 7.2 price ists 1.2 under it does not incude prices see trade practices prizes si to 18.1 private prescription forms, preprinted si to 9.1 & 9.2 professiona pubications 5.2 & si for definition of term promotiona aids 1.8 & 18.1 & si pubic assessment reports (European & UK) outside scope of the Code 1.2 under It does not incude provision of on the Internet 28.5 to the pubic si to 26.2 & 28.5 & si pubic heath campaigns si to 26.2 pubic reations activities 26 & si to 26.2 responsibiity for 26.6 pubic, reations with advertising to 1.1 & 26 & si disease awareness campaigns si to 26.2 enquiries from 26.4 & si exposed maiings 9.8 & si Internet 28 provision of information to 26 & si, 28 & si provision of sampes to not aowed pubic heath campaigns si to 26.2 quizzes si to 18.1 quotations 10.2 & si, 10.3 & 10.4 & si see aso 7.6 referee, independent 5.1, 5.2, 5.3, 7.2, 7.4, 7.5 & 7.6 references prohibition in abbreviated advertisements 5.9 references to pubished studies 7.6 & si, 7.8 & si reative risk, reference to si to 7.2 remote detaiing si to 9.9 repies to individua enquiries 1.2 & si repy paid cards si to 9.8 repy paid cards offering items to be deivered by representatives si to 15.3 see aso sampes, request forms 17.3 & si representatives genera 15 briefing materia 15.9 & si contract representatives si to 15 definition of term 1.7 deivering items si to 15.3 examinations 16.3 & si frequency & manner of cas on doctors 15.4 & si hospitaity and payments for meetings si to 15.3 identifying themseves 15.5 items deivered by representatives si to 15.3 prohibition on payments for interviews 15.3 & si provision of summary of product characteristics by representatives 15.8 & si training, genera 15.1, 16.1 & 16.3 & si reprints of artices, distribution of 10.1 & si reproduction of officia documents 9.6 risk/benefit profie si to 7.10 CODE OF PRACTICE 65

67 risk, reative and absoute si to 7.2 risk sharing agreements si to 18.1 room renta, payment 22.3 & si Roya Coege of Nursing case reports 13.5 consutation with on appointment of Appea Board independent registered nurse prescriber 3.2 on Code 19.2 Roya Pharmaceutica Society case reports 13.5 consutation with on appointment of Appea Board independent registered pharmacist 3.2 on Code 19.2 ruings by Appea Board 10 by Pane 7 safe', use of the word 7.9 & si sampes genera 17 definition of si to 17 distribution in hospitas 17.8 to the pubic not aowed identification sampes si to 17 abeing 17.5 maximum number of 17.2 posted request forms and their retention 17.3 & si size 17.4 starter packs si to 17 system of contro and accountabiity 17.9 titration packs si to 17 use as inducement use for patient treatment which medicines can be samped? 17.2 & si sanctions audit of company s procedures 10.4, 11.3 & 12.2 case reports 13 corrective statements 10.6 & 11.3 pre-vetting 10.4 & 11.3 pubication in medica, pharmaceutica and nursing press recovery of items 10.3 & 11.3 reports to Appea Board and ABPI Board 8, 11 & 12 reprimand and pubication 10.5 & 11.3 suspension/expusion from ABPI 12.2 specia provision for non ABPI companies 11.4 & 12.2 undertakings from companies rued in breach 7.1, 7.3 & 10.2 scientific service in charge of information genera 25.1 reports on adverse reactions by representatives 15.6 scientific service in charge of non-interventiona studies of marketed medicines 25.2 scope of the Code 1 & si scrutiny 17 Serious Fraud Office consutation with on Code 19.2 sexua imagery, use of si to 9.1 & 9.2 side-effects see adverse reactions size of promotiona materia abbreviated advertisements, size of 5.3 journa advertisements, size of 6 see aso extremes of format sponsorship of materia and meetings, discosure of 9.10 & 22.4 sponsorship of meeting attendance, discosure of 22.5 & si starter packs si to 17 statistica information, use of si to 7.2 see aso si to 7.8 on artwork, iustrations, graphs and tabes subsistence, provision of 22.1 & si & 22.2 & si substantiation of information, caims and comparisons 7.4 & 7.5 suitabiity and taste 9.1 & 9.2 & si summaries of product characteristics outside scope of the Code 1.2 under It does not incude need to consut 4.2 & 5.4 provision of by representatives 15.8 & si on the Internet 28.5 to the pubic si to 26.2 & 28.5 & si with press reeases and press packs si to 26.2 with sampes 17.5 summary in prescribing information 4.2 superatives 7.10 & si suspension of advertising on compaints from Medicines and Heathcare Products Reguatory Agency 9.2 suspension of materia or activities pending appea when required by Pane 7.1 & 7.3 switch and therapy review programmes si to 19.1 symposia see meetings tabes see artwork, iustrations, graphs and tabes taste in advertising si to 9.1 & 9.2 teaser advertising si to 9.1 & 9.2 teemessages, use of 9.9 & si to 15 teephone and text messages, use of 9.9 & si to 15 terms of trade see trade practices textbooks, provision of si to CODE OF PRACTICE

68 text messages, use of 9.9 & si to 15 the, use of the word si to 7.10 therapy review programmes si to 19.1 timing under compaints procedure genera 14 appeas 7.3 commenting on appea by compainant 7.4 commenting on appea by respondent 7.5 extensions 7.1, 7.3 & 14 payment of administrative charge 7.1, 7.2, 10.1 & 10.2 providing an undertaking on ruings by Appea Board 10.2 Pane 7.1 & 7.3 responding to compaint 5.4 suspension pending appea when required by Pane 7.1 & 7.3 titration pack see sampes si to 17 trade practices, prices, discounts, margins, etc si to 18.1 training training on Code 16.1 & si training of representatives 15.1, 16.1 & 16.3 & si transfers of vaue 24 centra patform for discosure si to 24.1 definition of term 1.10 & si traveing expenses 22 & si unauthorized medicines and unauthorized indications 3 & si see aso unicensed medicines undertakings by companies rued in breach 7.1, 7.3 & 10.2 undertakings, breach of 29 unique, use of the word si to 7.10 unicensed medicines, price ists of 1.2 & si voume of promotiona materia 11.2 & si vountary admissions by pharmaceutica companies 5.6 & 16.4 WHO Ethica criteria for medicina drug promotion see introduction to Code and page 60 withdrawa of compaints and appeas 15 wraparounds on journas si to 6.2 yeow cards 4.10 & 5.6 CODE OF PRACTICE 67

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