Compliance, Codes and Communications

Transcription

1 Compliance, Codes and Communications UPDATE Second 2012 Edition Payments for Services Donations Hospitality Trade Names Market Research Sponsorship Meetings Advisory Boards Booths Hospitality Posters Donations Advertisements Sponsorship Gifts Public Relations Gifts Sponsorship Posters Market Research Advertisements Booths Meetings Hospitality A practical guide to the ABPI code, with important European insights Dr Judith Grice

2 New Compliance Services from PharmaCodes Lunch and Learn Training Summaries of recent ABPI cases and any learning that may be taken from these are presented by a trainer from PharmaCodes Compliance. These interactive lunch time sessions can be arranged on either a quarterly or six monthly basis. The company will receive a copy of the PowerPoint presentation and one page summaries of the cases. Monthly ABPI Case Review Updates If you would rather present the ABPI case reviews yourself, we can supply Powerpoint presentations of the cases with presenter s notes on a monthly basis. Case Review Compendium Case Review Compendium is a database of ABPI cases searchable by Case number, Clause breached or Company name. PowerPoint presentations are available for each case or the entire quarterly review. One page summaries of the cases are also available for printing. PharmaCodes Compliance Existing Services Consultancy High quality adaptable consultancy services, tailored to your company s needs Review promotional and non promotional material and activities and act as final official company signatories Compliance training Pan European Marketing Codes or specifically the ABPI Code In house tailored to company requirements or open courses Audits Audits of policies and procedures to develop compliance and governance processes Preparation and development of SOPs Undertaking pre and post PMCPA audits Interim Compliance Solutions Providing in-house or remote compliance and medical affairs placements to support short or long term needs ICTAS Inernational Compliance Trained Agency Scheme Agencies trained by PharmaCodes Compliance during the past year or are about to receive training from PharmaCodes Compliance will be eligible to join ICTAS Details of all our services can be found on our website

3 APBI Second Update 2012 The ABPI Code 2011 was updated in order to meet the requirement to bring it into line with the changes made to the EFPIA Code in June The changes are in 3 areas: f fconstitution and Procedure; f f fprovision of Samples. f Working with Patient Organisations; 2012 Second Update Secondly, changes were made in light of the revised IFPMA international Code and changes to UK regulations. The second set of changes mostly concerned minor details rather than representing any fundamental changes. Only material changes are covered in this update. Constitution and Procedure The Constitution and Procedure has been amended so that in future where changes arise solely from amendments to the EFPIA Codes then the ABPI Board may decide that formal approval at an ABPI General Meeting is not necessary given that the ABPI is obliged to implement the EFPIA amendments. SECOND UPDATE

4 Definition of Promotion and Health Professional The latest code update includes some slightly revised definitions for promotion / advertising and health professionals. These could be important when considering activities described in later chapters of the book. 1 Basic Principles CHAPTER Promotion (advertising) is now defined as activities which promote the administration, consumption, purchase, prescription, recommendation, supply or use of medicines. This longer list clarifies that activities targeted at, for example, those who make recommendations concerning medicines could be considered as advertising. Some communications are classified as non-promotional. New additional guidance is given on price lists of unlicensed medicines. These are not classified as promotion providing they don t include product claims and can be sent to appropriate recipients at reasonable intervals or in response to enquiries. However the pro-active distribution of such price lists in a promotional manner or including them on exhibition stands isn t allowed. Mandatory wording Clauses 4.10 and 5.6 (page 3 - changed requirement) Both full and abbreviated advertisements must include an adverse reaction reporting statement. The text for that statement has changed to refer to a different website address. The statement must now read: Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to [name of relevant company] Substantiation Clause 7.4 (page 16 clarification of requirement) On request, companies must substantiate information they provide but an exemption is given with respect to indications approved in the marketing authorisation. It is now made clear that requests for substantiation of approved indications may not be refused, but rather providing a copy of the SmPC will serve to satisfy the company s responsibility. 2 COMPLIANCE, CODES AND COMMUNICATIONS

5 Changes to obligatory information for abbreviated advertisements 3 Printed Materials CHAPTER See Table 6 page44 A statement concerning further information being available from the company has always been required. Now companies must make certain information available on a website and make reference to the website address in abbreviated advertisements. So a typical statement in an abbreviated ad. would now read: Information about [Product], including adverse reactions, precautions, relevant contra-indications and method of use can be found at [website URL]. On the website companies should provide the prescribing information or SmPC, together with cost. You can of course include the trade name as a heading to the information on the website but the non-proprietary name(s) must also be included adjacent to the trade name and in easily readable type. SECOND UPDATE

6 Working with Patient Organisations The appropriateness of relationships between pharmaceutical companies and patient organisations (POs) has featured widely in the press with industry critics alleging improper influence. The ABPI Code outlines requirements for acceptable behaviour and for public reporting of support provided. Some requirements are based on a dedicated European industry code: EFPIA Code of practice on relationships between the pharmaceutical industry and patient organisations. The fundamentals Companies can interact with patient organisations and support their activities. As fellow actors in healthcare with a number of common interests it is entirely appropriate that such interactions occur and are encouraged. The range of organisations that the term patient organisations covers isn t defined in the ABPI Code but in the EFPIA Code it is defined as: not-for-profit organisations (including the umbrella organisations to which they belong), mainly composed of patients and/or caregivers, that represent and/or support the needs of patients and/or caregivers. This is a reasonable working definition for UK purposes. Organisations that support people with disabilities, carers and relatives and consumers organisations are all included. If a patient organisation is not well known it is advisable to confirm that it is genuine and that it is an organisation that your company is happy to be associated with. It is important to feel confident that the PO would not utilise your company s support for unacceptable purposes outside the agreement with them. The Code applies the same principles relating to quality of information and hospitality/meetings arrangements as for interactions with other groups and individuals. The main thrust of the provisions specific to patient organisations interactions 5 CHAPTER Patient Information Hints & Tips Although the Code does permit sole sponsorship of a patient organisation or a programme this is best avoided wherever possible. 4 COMPLIANCE, CODES AND COMMUNICATIONS

7 is around ensuring transparency of the arrangements. Not only should the interactions comply with the rules and be appropriate and proper but also this should be open to public scrutiny. SECOND UPDATE 2012 Hints & Tips Patient organisations may wish to make their own transparency listing available but this does not negate the responsibility of companies also to make a public declaration. A company is not allowed to require that it be the sole funder of a patient organisation or any of its programmes. The intent here is to ensure that a patient organisation does not become dependent on one company a situation that is seen by many to be undesirable. However there are situations when single-company sponsorship is unavoidable; for example when a group is first set up, or when there is very limited interest in the condition that the patient organisations is concerned with, or perhaps when a single company is invited to support a small proportion of the costs of a particular programme. Don t forget that, in addition to the ABPI Code and the Regulations, there are other codes and guidelines that cover the relationships between companies and patient organisations. In most cases the patient groups themselves, rather than companies, are responsible for compliance but when working with new or inexperienced patient organisations you may wish to draw their attention to these rules. Transparency requirements Ensure that the involvement of your company is made clear in all interactions with patient organisations. Sponsorship and support for patient organisations must be declared. Each company must make publicly available, at a national or European level, a list of patient organisations to which it provides financial support and/or significant indirect/nonfinancial support. The monetary value of any financial support must be declared, the 2012 Code removes the 250 threshold and now all support must be declared. Indirect and non-financial support must also, whenever possible, be allocated a value and listed. It must include a description of the nature of the support that is sufficiently complete to enable an average reader to form an understanding of the significance of the support. It is the value to the organisation, rather than the cost to the company, that is important. Where significant non-financial support cannot be assigned a meaningful monetary value then the published information must clearly describe the non-monetary value the organisation receives. Both core funding and unrestricted grants as well as funding for specific projects must be listed. As discussed the listing must include short descriptions of the nature of the support 5

8 for each patient organisation. You may, if you wish, also include an indication of the patient organisation s total income and/or your company s support as a percentage of their total income. Of course to do this you are reliant on information they provide publicly or in response to a request. For international patient organisations you must also decide which part it is relevant to quote. While it is likely to be straightforward to identify a value for indirect support for which you are invoiced (e.g. the services of a PR agency) it can be difficult to allocate a monetary value to support such as loaning a meeting room or providing the time of an employee. A suggestion is to outline clearly on the site where the information is displayed the criteria you have applied to calculate monetary value of non-monetary support. The requirement to include the monetary value of support regardless of the level must be made publically available by the end of the first quarter of 2013 and applies to activities commenced on or after 1st January 2012 or ongoing on that date. Until this information is made publically available, the requirements of Clause 23.7 of the 2011 Code with respect to public declarations remain applicable i.e. The published information must include the monetary value of financial support and or significant indirect non-financial support provided to a PO with a value to the organisation of 250 per project or more (excluding VAT). The listing is usually made on a company website. In the unlikely event that you do not have a suitable website, and don t wish to set one up, then inclusion in an annual report is a suitable alternative. However setting up a website is easy and cheap to do. The listing can be made nationally or at a European level. Listing requirements are Europe-wide and it is important that company s national affiliates, and multinational headquarters, liaise over data collection and display. Some patient organisations span more than one country and, according to the EFPIA Code, the declaration must be made in the country where the organisation has its main European location. Support from an overseas headquarters for a UK-based patient organisation, or relating to an activity that takes place in the UK must be declared in the UK listing. It could be easy to miss listing an item of support, particularly in large organisations, so companies should establish clear procedures to capture all relevant financial and non-financial support. The list must be updated at least once a year although you may choose to update it more frequently. You are encouraged to respond to enquiries about the support you provide between the annual listings. A continuously updated database is an obvious way to enable your company to do this. 6 COMPLIANCE, CODES AND COMMUNICATIONS

9 Written Agreements and Contracts Written Agreements You must have in place a written agreement (or several if this is easier) with every patient organisation with which you have a relationship. This must set out exactly what has been agreed in relation to every significant activity or ongoing relationship including core funding. Note that you do not have to make the agreement public although some companies may wish to do this as part of the listing required by the transparency clause. The written agreement must be certified by your nominated signatories. You may wish to ask your lawyers to draft the written agreement in the form of a legal contract, particularly for substantial or complex support, but a simple letter of agreement that sets out the arrangements is sufficient and is perhaps more appropriate for small-scale support. The Code sets out elements that must be included in the written agreement: f fthe name of the activity; f fthe names of the organisations involved (pharmaceutical company, patient organisations and any third parties which will be brought in to help); f fthe type of activity (e.g. unrestricted grant, specific meeting or publication etc.); fthe f objectives; f fthe respective roles of the company and the patient organisation; fthe f time-frame; f fthe amount of funding; f fa description of significant indirect/non-financial support (e.g. the donation of public relations agency time or free training courses); f fa statement that all parties are fully aware that sponsorship must be clearly acknowledged and apparent from the start; f fthe code or codes of practice which will apply; f fthe signatories to the agreement; f fthe date of the agreement. The agreement can also set out operational details or these can be included in a separate document. Documentation must be in sufficient detail so that if personnel change the arrangements and responsibilities are clearly set out. It will be particularly important to outline who is responsible for what, e.g. who will review and approve outputs and meeting arrangements. Certification (or examination) requirements for outputs and activities (e.g. meetings held outside the UK) should SECOND UPDATE

10 be documented from the outset so there is no misunderstanding and sufficient time must be allowed for this to occur. Contracts There is a new clause, Clause 23.8, in the 2012 Code requiring a written contract with patient organisations when they provide services to companies, these services are only allowed for the purpose Hints & Tips Some patient organisations will have their own written agreement templates, particularly when multiple sources of funding are received. You can use their agreement text and avoid having two agreements covering the same arrangement but it must cover all the points required by the ABPI Code. of supporting healthcare or research. POs may be engaged as experts and advisors e.g. participation in advisory board meetings or as speakers at meetings. The written contract is similar to those which must be put in place when healthcare professionals are engaged as consultants. It must be agreed in advance of the commencement of the services and specify the type of service to be provided and the basis for payment of the service. The agreement must fulfil the following criteria: ffidentify a legitimate need for the service; ffthe criteria for selecting the service must relate to this legitimate need; ffthe persons responsible for selecting the services must have the necessary expertise to evaluate whether the experts or advisors chosen meet the need which has been identified; ffthe extent of the service must not be more than is reasonably required to achieve the need; ffthe contracting company must maintain records and make appropriate use of the service provided; ffthe engagement of services must not be an inducement to recommend a particular medicine; ffthe compensation for the services must be of a fair market value and setting up token consultancy arrangements must not be used as a means of making payments to patient organisations; ffas a matter of good practice companies are encouraged to include a clause in the written contracts requiring that the PO is obliged to declare that they have provided paid services to the company whenever they write or speak in public about a matter that is the subject of the agreement or any other issue relating to the company; ffeach company must make publicly available, at a national or European level, a list of patient organisations that it has engaged to provide 8 COMPLIANCE, CODES AND COMMUNICATIONS

11 significant contracted services. The company must make publically available a description of these services in sufficient detail to enable an average reader to understand the arrangement (without divulging confidential information). The total amount paid per organisation must be reported and the list of organisations engaged must be updated annually. Information provided to patient organisations It is important to recognise that the Code, in referring to patient organisations, does not create a special category. Information on health and medicines provided to patient organisations is subject to the Code rules, and also the law, that prohibit promotion of prescription medicines to the public. The Code sets out guidance on circumstances in which the provision of information to the public, patients and carers through patient organisations would not be considered as advertising. Advertising prescription-only medicines to the public, including patient organisations, is not permitted. The information you provide to patient organisations should be appropriate to their requirements. Where you provide information on prescription-only medicines to patient organisations it will be important to make clear the purpose of that information, how it will be used and who has editorial responsibility over outputs. It could be that the information is required for their information service library, or to produce a particular leaflet. A company must not seek to influence the text of a patient organisation s material in a manner favourable to its own commercial interests. However if you are able to review draft material you can ask that any factual inaccuracies be corrected. You can provide information to patient organisations in anticipation of a Health Technology Assessment (e.g. NICE). It must be accurate, not misleading, nonpromotional in nature and in every other way comply with the quality requirements set out in the Code. Remember also that information for patients must be certified. Information for patient groups is not immune from this requirement, although Key Point Certification is required: information provided in response For the written agreement to a specific question need only be For meetings abroad examined for compliance rather For outputs/activities that the company has a than certified. (Refer to Review meaningful opportunity to influence and approval of non-promotional For materials that the company intends to distribute or use information Page 77.) SECOND UPDATE

12 Support for outputs and activities Outputs supported by your company may or may not require certification by the company, in their final form, depending on whether you have had a meaningful opportunity to influence the content. Any outputs that the company distributes will require certification. Your support for a patient organisation s outputs and activities does not necessarily mean that you adopt responsibility for all aspects of them. A clearly worded agreement is key to setting out your responsibilities. You may, for example, provide support for the technical and design aspects of a patient-group website but this doesn t make you responsible for the content; unless of course you should have had a reasonable expectation that the site was set up to do something unacceptable under the Code such as promote your prescription-only product. You could also fund the printing or distribution of their newsletter but the written agreement should make clear that you have no influence over the content. You can link to patient organisations websites from your own sites, e.g. from the reference information you provide. However be cautious about linking to their sites from your advertising and disease awareness campaigns. A deep link to a page referring to your product could be at particular risk of being considered advertising and of course you will have no control over any content updates. Where you provide links it is generally best that these point to the home page of the organisation. You can sponsor patient organisations meetings but do ensure that you obtain full details about the programme content and meeting arrangements. You shouldn t sponsor an event designed to, in effect, promote your product and your funding should not be used to pay for unacceptable activities such as business class air fares for delegates, inappropriate hospitality, etc. Although the requirements of Clause 19 apply in relation to the provision of hospitality at meetings, i.e. hospitality should not extend beyond the bona fide delegate, the new supplementary information to Clause 23.2 does allow for companies to pay reasonable costs for an accompanying carer. This is only in the case of clear health needs such as disability where subsistence, accommodation, registration fees and travel expenses of the carer may be funded. Hints & Tips Choose the declaration of company involvement to reflect the arrangements. Some possibilities are: Supported by an unrestricted educational grant from Company Produced by Company as a service to patients Produced on behalf of Company Produced by XXX with the support of Company 10 COMPLIANCE, CODES AND COMMUNICATIONS

13 You may receive requests to fund attendance by patient organisations representatives at good-quality medical meetings that are open to non-medical delegates. The delegate may well be exposed to advertising of prescription medicines, e.g. in the exhibition hall and the PMCPA has cautioned that unintentional exposure of patient group representatives to promotion could result in a breach of the Code. However sponsorship of attendance could be argued to be acceptable if the main purpose of the meeting is truly non-promotional scientific exchange and exposure to advertising material is, perhaps, rather like a lay reader seeing advertisements in a medical journal to which they subscribe. It would not be appropriate however to require attendance at a company sponsored symposium or otherwise direct the delegate to information on your medicines. Support for meeting attendance should be for the organisation and not to individuals. You must not use a patient organisation s logo or other proprietary material without describing the specific purpose and the way in which it will be used and getting their written agreement. The involvement of your company in the provision of information must always be made clear even when a third party (e.g. an agency working on your behalf) provides the information. Simply, if the company has been involved in some way with the provision of information this must be readily apparent to the recipient. The wording chosen to communicate the company involvement must be carefully chosen and must reflect the arrangements accurately. This means that a standard phrase is unlikely to be appropriate in all circumstances. In particular do not use phrases such as unrestricted educational grant unless the company was truly not involved in editing or constructing the material. The declaration must appear in a prominent position so that readers notice it before starting to read the content. For a booklet or leaflet that usually means a clear and prominent place on the front page. SECOND UPDATE

14 CHAPTER 6 Samples The ABPI Code has been changed to reflect the new EFPIA Code issued in 2011 i.e. 4 samples per HCP of a new product per year for a maximum of 2 years after the HCP first requests a sample. This Services to Benefit Patients is much more restrictive than the ABPI 2011 Code requirements and applies with effect from 1st January 2012 in relation to new medicines launched on the UK market on or after that date. However for medicines launched on the UK market before 1st January 2012, samples may be provided in accordance with the 2011 Code until 31st December 2013 (i.e. 10 samples per HCP per year for 10 years after product is launched on the UK market.) A new product for the purpose of this clause regarding samples is a product for which a new marketing authorisation has been granted, either fffollowing the initial application; fffollowing a Marketing Authorisation for a new indication that includes new strengths and / or dosage forms. The following DO NOT count as a new product with respect to sample provision. ffthe extension of a marketing authorisation to include new strengths and/or dosages for existing indications; ffadditional pack sizes. Other requirements of the Code with respect to samples remain unchanged and are as follows: A sample is a small supply of a medicine given to HCPs so that they can familiarise themselves with it and gain experience in dealing with it. It can only be provided to HCPs qualified to prescribe the product. They must not be supplied to members of the public or administrative staff. 12 COMPLIANCE, CODES AND COMMUNICATIONS

15 The following are NOT samples: fftitration packs; fffree goods; ffbonus stock; ffstarter packs. (Note that starter packs are now prohibitied. Department of Health policy is that they are not appropriate.) Conditions for supplying samples The following apply when providing samples for new products: ffno more than 4 samples of a product can be supplied to an individual HCP per year (refer to page 10 for further details); ffsamples may only be provided to a HCP for 2 years after the individual HCP first requests a sample of a particular new medicine; ffsamples must not be provided as an inducement to prescribe, supply, administer, recommend, buy or sell a medicine; ffthey must not be given for the sole purpose of treating patients ffthey can only be provided in response to written requests which have been signed and dated; ffthey must be marked free medical sample not for resale ; ffthey must be accompanied by a copy of the SPC; ffthe smallest pack available on the UK market must be supplied; ffsamples of medicines containing substances listed in schedules I, II or IV of the narcotic drugs convention or in schedules I IV of the psychotropic substances convention cannot be supplied. Delivery of samples The following requirements must be met: ffif distributed by sales representative, they must either be handed directly to the HCP requesting them or to a person authorised to receive them on behalf of the HCP; f fpackages delivered by post must be childproof; f fsupply in hospitals must comply with individual hospital protocols. Control, accountability and storage of samples Adequate systems must exist for controlling, accounting, distributing and storing samples. This should include: ffrecords of number of samples supplied to each HCP; SECOND UPDATE

16 f frecords of delivery to representatives; f fcorrect storage conditions: They must be stored and distributed at the correct temperature, as per the product licence They must be stored securely (Therefore for both of the above reasons they must not be stored in a car); f fthere must be audits of stock, e.g. to ensure that all stock is accounted for and expiry dates have not been exceeded; f fthere must be a mechanism for return of the samples to the company. 10 CHAPTER Europe Europe Chapter 10 Table 24 should be deleted as it no longer applies. The EFPIA Code 2011 changes require that national association Codes reflect these changes from 1st January Therefore there should no longer be a difference between the national codes with respect X to sample Table 24: Country guide for the provision of samples provision once COUNTRY WHAT IS ALLOWED the transitional Austria Up to one year after initial distribution. Sufficient to evaluate treatment success of 10 patients but maximum of 30 per year. After one year, maximum of 2 per request/per phases have recipient, with a maximum of 5 per year. No samples of psychotropics/narcotics. Belgium Only to persons qualified to prescribe in response to signed/dated request to company. ended. Must be accompanied by SPC and wording Free sample. May not be offered for sale must appear on packaging. Czech Republic Distribution must accord with the law and regulation issued by the State Institute for Drug Control (SUKL). Finland Free samples of medicines can be given only to persons who are authorised to prescribe or supply them. Each recipient can be given only one free sample of each medicinal product, strength and pharmaceutical form in one calendar year. Narcotics, psychotropic substances cannot be given. Each sample must be accompanied with a respective summary of product characteristics. The pharmaceutical company must keep records. France A limited number of 10 per year per recipient and must be in response to a signed and dated request. Germany Can only be supplied in response to a written request. Only 2 samples of each product per HCP per year. Must be labelled Sample - not for commercial use. Adequate records and control must be kept. Greece Free samples of medicines can be given only to persons who are authorised to prescribe or supply them. Narcotics, psychotropic substances cannot be given. Each sample must be accompanied with a SPC. The pharmaceutical company must keep records. Ireland A limited number of 6 per year per recipient and must be in response to a signed and dated request. A copy of the SPC must be supplied and the company must keep records. 14 COMPLIANCE, CODES AND COMMUNICATIONS

17 About PharmaCodes Compliance... Established in 2007, PharmaCodes Compliance Ltd provides expert advice in pharmaceutical marketing Compliance, Codes and Communications on a global basis with a particular emphasis on the European market. We provide support to a variety of clients, pharmaceutical companies, advertising agencies and medical communications agencies. The PharmaCodes team blends extensive therapeutic and pharmaceutical industry experience with outstanding knowledge of global pharmaceutical marketing compliance. Our mission is to make our clients more competitive by freeing them to spend time on marketing their products rather than worrying if the marketing campaign is compliant. This can be particularly time consuming for those producing or approving pan-european or global campaigns. Call +44 (0) or admin@pharmacodes.com to discuss your requirements or book a course Visit our website for more information about compliance

18 Compliance, Codes and Communications A practical guide to the ABPI code, with important European insights Second Update 2012 Dr Judith Grice Compliance, Codes and Communications First published nd edition published 2010 ISBN This update published by Stanford Publishing Limited 2012 Stanford Publishing Limited All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without prior permission in writing from the publishers. Whilst the advice and information contained in this update are believed to be true and accurate, the authors, publisher and PharmaCodes Compliance Ltd make no representation, express or implied, with regard to the accuracy of the information contained in this book and cannot accept any legal responsibility or liability for any errors or omissions that may be made. Layout by 2m Partnership Limited